Devices for reducing the size of an internal tissue opening

ABSTRACT

A medical system for treating an internal tissue opening can include a closure device and associated delivery device. The closure device can include a body portion operatively associated with a first anchor and a second anchor. The body portion can include a plurality of segments defining a multi-cellular structure. The closure device can be configured to apply lateral force to tissue of the internal tissue opening to bring tissue together. The closure device can have a substantially flat aspect, and have a depth thickness that is substantially greater than the thickness or width of a majority of the members forming the closure device to reduce out of plane bending. The closure device can also include a member adapted to induce tissue growth.

CROSS-REFERENCE TO RELATED APPLICATIONS

The present application claims the benefit of U.S. ProvisionalApplication No. 61,179,640, filed May 19, 2009, and U.S. ProvisionalApplication No. 61/260,334 filed Nov. 11, 2009. The present applicationis also a continuation-in-part of U.S. patent application Ser. No.11/836,000 filed Aug. 8, 2007, U.S. patent application Ser. No.11/836,016 filed Aug. 8, 2007, and U.S. patent application Ser. No.11/836,123 filed Aug. 8, 2007, each of which claims priority to: U.S.Provisional Application No. 60/821,949 filed Aug. 9, 2006; U.S.Provisional Application No. 60/821,947 filed Aug. 9, 2006; U.S.Provisional Application No. 60/829,507 filed Oct. 13, 2006; U.S.Provisional Application No. 60/866,047 filed Nov. 15, 2006; and U.S.Provisional Application No. 60/942,625 filed Jun. 7, 2007. Thedisclosures of each of the above-listed applications are herebyincorporated in their entireties by reference herein.

The present application is additionally related to the following U.S.patent applications: U.S. patent application Ser. No. 11/836,037, filedon Aug. 8, 2007; U.S. patent application Ser. No. 11/836,051, filed onAug. 8, 2007; U.S. patent application Ser. No. 11/836,013, filed on Aug.8, 2007; U.S. patent application Ser. No. 11/836,026 filed on Aug. 8,2007; and U.S. application Ser. No. 12/413,334 filed Mar. 27, 2009. Thedisclosures of each of the above-listed applications are herebyincorporated in their entireties by reference herein.

TECHNICAL FIELD

The present invention relates generally to medical devices and methodsof use for treating an internal tissue structure. More particularly, thepresent invention relates to medical devices, systems, and methods forreducing the size of an internal tissue opening.

BACKGROUND

Physical malformations or defects that are present at birth can bedetrimental and even lethal when left uncorrected. A patent foramenovale (“PFO”) is an example of a cardiac birth defect that can beproblematic and even result in death when combined with other factorssuch as blood clots or other congenital heart defects. A PFO occurs whenan opening between the upper two chambers of the heart fail to closeafter birth.

Some of the problems associated with a PFO can occur when a blood clottravels from the right to the left atria of the heart through the PFO,and lodges in an artery that feeds blood to the brain. A blood clot inthe left atrium can be passed through the aorta and travel to the brainor other organs, and cause embolization, stroke, or a heart attack. APFO can be treated by being closed by a surgical procedure.Additionally, other similar defects (e.g. septal or otherwise) wheresome tissue needs to be closed in order to function properly can includethe general categories of atrial-septal defects (“ASDs”),ventricular-septal defects (“VSDs”) and patent ductus arteriosus(“PDA”), and the like.

FIGS. 1A-1C depict various views of a heart having a PFO. The heart 10is shown in a cross-section view in FIG. 1A. In a normal heart 10, theright atrium 30 receives systemic venous blood from the superior venacava 15 and the inferior vena cava 25, and then delivers the blood viathe tricuspid valve 35 to the right ventricle 60. However, in thedepicted heart 10 a septal defect, which is shown as a PFO 50, ispresent between the right atrium 30 and the left atrium 40.

The PFO 50 is depicted as an open flap on the septum between the heart'sright atrium 30 and left atrium 40. In a normal heart 10, the leftatrium 40 receives oxygenated blood from the lungs via pulmonary artery75, and then delivers the blood to the left ventricle 80 via the mitralvalve 45. In a heart 10 having a PFO 50 some systemic venous blood canalso pass from the right atrium 30 through the PFO 50 and mixes with theoxygenated blood in left atrium 40, and then is routed to the body fromleft ventricle 80 via aorta 85.

During fetal development of the heart 10, the interventricular septum 70divides the right ventricle 60 and left ventricle 80. In contrast, theatrium is only partially partitioned into right and left chambers duringnormal fetal development, which results in a foramen ovale fluidlyconnecting the right and left atrial chambers. As shown in FIG. 1B, whenthe septum primum 52 incompletely fuses with the septum secundum 54 ofthe atrial wall, the result can be a tunnel 58 depicted as a PFO 50.

FIG. 1C provides a view of the crescent-shaped, overhangingconfiguration of the septum secundum 54 from within the right atrium 30in a heart 10 having a PFO 50. The septum secundum 54 is defined by itsinferior aspect 55, corresponding with the solid line in FIG. 1C, andits superior aspect 53 represented by the phantom line, which is itsattachment location to the septum primum 52. The septum secundum 54 andseptum primum 52 blend together at the ends of the septum secundum 54.The anterior end 56 a and posterior end 56 p are referred to herein as“merger points” for the septum secundum 54 and septum primum 52. Thelength of the overhang of the septum secundum 54, which is the distancebetween superior aspect 53 and inferior aspect 55, increases towards thecenter portion of the septum secundum as shown.

The tunnel 58 between the right atrium 30 and left atrium 40 is definedby portions of the septum primum 52 and septum secundum 54 between themerger points 56 a and 56 p which have failed to fuse. The tunnel 58 isoften at the apex of the septum secundum 54 as shown. When viewed withinright atrium 30, the portion of the septum secundum 54 to the left oftunnel 58, which is referred to herein as the posterior portion 57 p ofthe septum secundum, is longer than the portion of the septum secundum54 to the right of tunnel 58, which is referred to herein as theanterior portion 57 a of the septum secundum 54. In addition to beingtypically longer, the posterior portion 57 p also typically has a moregradual taper than the anterior portion 57 a as shown. The anteriorpocket 59 a is the area defined by the overhang of the anterior portion57 a of the septum secundum 54 and the septum primum 52, and it extendsfrom the anterior merger point 56 a toward the tunnel 58. Similarly, theposterior pocket 59 p is the area defined by the overhang of theposterior portion 57 p of septum secundum 54 and the septum primum 52,and it extends from the posterior merger point 56 p toward the tunnel58.

Conventional treatments for PFO, and other related conditions havegenerally involved invasive surgery, which also presents a risks to apatient. Although there are some less invasive treatments for PFO, suchtreatments have been less efficient at closing the PFO opening thantechniques involving invasive surgery.

BRIEF SUMMARY OF THE INVENTION

The invention relates to a medical system, devices and methods of usefor reducing the size of an internal tissue opening, such as a PatentForamen Ovale (“PFO”). In one embodiment of the invention, the medicalsystem can include a closure device and an associated delivery device.The medical system can be configured to enable a practitioner toselectively position and deploy the closure device in an internal tissueopening to approximate, or in other words bring together the tissue ofthe opening.

In accordance with one embodiment of the present invention, a medicaldevice deployable at least partially within a hole defined in a tissuestructure between a first atrium and a second atrium of a heart, thehole defining an axis oriented axially through the hole, is provided.The medical device includes a frame configured to assume a substantiallyflat configuration oriented substantially parallel to, or extendingsubstantially along, the axis of the hole when in an intended,as-deployed state within the tissue structure. The frame includes acentral portion with at least one proximal anchor and at least onedistal anchor. The at least one proximal anchor and the at least onedistal anchor each configured to be substantially coplanar with thecentral portion, and the at least one distal anchor configured to extendin the first atrium and the at least one proximal anchor configured toextend in the second atrium. The at least one distal anchor including aplurality of anchor frame segments each extending from the centralportion.

In one embodiment, the at least one distal anchor includes a unitarymulti-cellular structure. In another embodiment, the plurality of anchorframe segments may include a multi-cellular structure. Further, theplurality of anchor frame segments may include at least three reinforcedsegments. Furthermore, the plurality of anchor frame segments mayinclude at least two anchor frame segments that extend from the centralportion and are substantially parallel to each other along at least aportion along their respective length. In addition, the at least onedistal anchor may include two distal anchors each with at least onereinforced segment, the at least one reinforced segment for each of thetwo distal anchors each extend from a location directly adjacent to eachother.

In accordance with another embodiment of the present invention, amedical device deployable at least partially within a hole defined in atissue structure between a first atrium and a second atrium of a heart,the hole defining an axis oriented axially through the hole, isprovided. The medical device includes a frame configured to assume asubstantially flat configuration oriented substantially parallel to, orextending substantially along, the axis of the hole when in an intended,as-deployed state within the tissue structure. The frame includes acentral portion with at least one proximal anchor and at least onedistal anchor. The at least one proximal anchor and the at least onedistal anchor each configured to be substantially coplanar with thecentral portion. The at least one distal anchor configured to extend inthe first atrium and the at least one proximal anchor configured toextend in the second atrium. The at least one proximal anchor includingone or more engaging members having a wave-crest configuration.

In one embodiment, at least one of the engaging members include a baseportion, a peak portion and an edge portion. The base portion extendsfrom the at least one proximal anchor, the peak portion having a surfaceat a peak of the at least one engaging member, and the edge portionextends from the peak portion. In another embodiment, the peak portionincludes an atraumatic surface.

In another embodiment, the medical device includes a tissue growthmember configured to be thermally attached to the frame. In stillanother embodiment, the medical device includes multiple clips extendingfrom portions of the central portion of the frame, the multiple clipsconfigured to attach a tissue growth member to the frame.

In accordance with another embodiment of the present invention, amedical device deployable at least partially within a hole defined in atissue structure between a first atrium and a second atrium of a heart,the hole defining an axis oriented axially through the hole, isprovided. The medical device includes a frame configured to assume asubstantially flat configuration oriented substantially parallel to, orextending substantially along, the axis of the hole when in an intended,as-deployed state within the tissue structure. The frame includes acentral portion with at least one proximal anchor and at least onedistal anchor. The at least one proximal anchor and the at least onedistal anchor each configured to be substantially coplanar with thecentral portion. The at least one distal anchor configured to extend inthe first atrium and the at least one proximal anchor configured toextend in the second atrium. The at least one proximal anchor includingat least two proximal anchor segments extending from the central portionand extending substantially parallel with each other.

In accordance with another embodiment of the present invention, amedical device deployable at least partially within a hole defined in atissue structure between a first atrium and a second atrium of a heart,the hole defining an axis oriented axially through the hole, isprovided. The medical device includes a frame configured to assume asubstantially flat configuration oriented substantially parallel to, orextending substantially along, the axis of the hole when in an intended,as-deployed state within the tissue structure. The frame includes acentral portion with at least one proximal anchor and at least onedistal anchor. The at least one proximal anchor and the at least onedistal anchor each configured to be substantially coplanar with thecentral portion. The at least one distal anchor configured to extend inthe first atrium and the at least one proximal anchor configured toextend in the second atrium. The central portion includes multiplestruts to define a multi-cellular structure and at least two of themultiple struts extend substantially parallel and alongside each other.

In one embodiment, the multiple struts are substantially similar inlength. In addition, the at least two of the multiple struts may extendalong a proximal portion of the frame and may be configured to reinforcethe at least one proximal anchor. Further, the at least two of themultiple struts may extend along a distal portion of the frame and maybe configured to reinforce the at least one distal anchor.

In another embodiment an expandable medical device is provided that isdeployable at least partially within a tissue structure and adjacent aleft atrium of a heart. The device comprises a multi-cellular centralframe portion configured to self expand from a first, non-tubularorientation to a second, non-tubular orientation, the first orientationbeing substantially similar to a collapsed orientation within acatheter, the second orientation being substantially similar to anorientation wherein the central frame portion is deployed and operablesubstantially within the tissue structure and adjacent the left atrium.The central frame portion comprises a plurality of interconnectingcentral frame support segments defining at least two apertures. At leastone of said central frame support segments has a length and a width, thewidth varying along at least a portion of the length. At least oneanchor is linked to said multi-cellular central frame portion.

In yet another embodiment, an expandable medical device is providedwherein the device is deployable at least partially within a holedefined in a tissue structure between a first atrium and a second atriumof a heart, the hole defining an axis oriented axially through the hole.The expandable medical device includes a frame configured to assume asubstantially flat configuration oriented substantially parallel to, orextending substantially along, the axis of the hole when in an intended,as-deployed state within the tissue structure. The frame comprises acentral portion, at least one proximal anchor and at least one distalanchor. The frame is configured to move between a first orientation anda second orientation. The central portion comprises a plurality of framesegments defining a multi-cellular structure, the at least one proximalanchor and said at least one distal anchor each being configured toextend substantially coplanar with said central portion. The at leastone proximal anchor is configured to extend in the first atrium and theat least one distal anchor is configured to extend in the second atrium.

In accordance with a further embodiment, a medical device is providedthat is deployable at least partially within a hole defined in a tissuestructure, the hole defining an axis oriented axially through the hole.The medical device includes a framework configured to assume asubstantially flat configuration oriented substantially parallel to, orextending substantially along, the axis of the hole when in a state forintended deployment within the tissue structure. The framework comprisesa central portion and at least one anchor extending from said centralportion. The central portion includes central frame segments having alength and a width, wherein the width of at least one of said centralframe segments varies along at least a portion of the length of the atleast one of said central frame segments in a tapered configuration.

In accordance with yet a further embodiment, a medical device isprovided that is deployable at least partially within a hole defined ina tissue structure, the hole defining an axis oriented axially throughthe hole. The medical device includes a framework configured to assume asubstantially flat configuration oriented substantially parallel to, orextending substantially along, the axis of the hole when in a state forintended deployment within the tissue structure. the framework comprisesa central portion and at least one anchor extending from said centralportion. The central portion includes central frame segments, wherein atleast one of the central frame segments includes a longitudinal lengthdimension and has an aspect ratio of a depth dimension to a lateralwidth dimension of at least 2 to 1, wherein the depth dimension isdefined to extend substantially perpendicular relative to thesubstantially flat configuration of the framework.

In accordance with another embodiment, an expandable medical device isprovided that is deployable at least partially within a hole defined ina tissue structure between a first atrium and a second atrium of aheart, the hole defining an axis oriented axially through the hole. Themedical device includes a framework configured to assume a substantiallyflat configuration oriented substantially parallel to, or extendingsubstantially along, the axis of the hole when in a state for intendeddeployment within the tissue structure. The framework comprises acentral portion, a first proximal anchor, a second proximal anchor andat least one distal anchor extending from said central portion. Thefirst and second proximal anchors are configured to extend in the firstatrium and said at least one distal anchor configured to extend in thesecond atrium. The first proximal anchor and said second proximal anchoreach include a plurality of anchor frame segments, wherein at least twoof the plurality of anchor frame segments extend substantially parallelto each other along at least a portion of their respective lengths foreach of the first proximal anchor and the second proximal anchor.

In yet a further embodiment, an expandable medical device is providedthat is deployable at least partially within a hole defined in a tissuestructure between a first atrium and a second atrium of a heart, thehole defining an axis oriented axially through the hole. The medicaldevice includes a frame configured to assume a substantially flatconfiguration oriented substantially parallel to, or extendingsubstantially along, the axis of the hole when in a state for intendeddeployment within the tissue structure. The frame comprises a centralportion and at least one proximal anchor and at least one distal anchorextending from said central portion. The at least one proximal anchor isconfigured to extend in the first atrium and the at least one distalanchor is configured to extend in the second atrium. A tissue growthmember is attached to the frame and comprises: a first elongate tissuegrowth portion positioned along the central portion of the frame andconfigured to be positioned in the hole and oriented substantiallytransverse to the axis of the hole; and a second elongate tissue growthportion positioned proximal to the first elongate tissue growth portion,the second elongate tissue growth portion configured to be orientedsubstantially transverse to the axis of the hole.

These and other advantages and features and configurations of thepresent invention will become more fully apparent from the followingdescription and appended claims, or may be learned by the practice ofthe invention as set forth hereinafter.

BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS

To further clarify the above and other advantages and features of thepresent invention, a more particular description of the invention willbe rendered by reference to specific embodiments thereof which areillustrated in the appended drawings. It is appreciated that thesedrawings depict only typical embodiments of the invention and aretherefore not to be considered limiting of its scope. The invention willbe described and explained with additional specificity and detailthrough the use of the accompanying drawings in which:

FIGS. 1A-1C illustrate exemplary views of a heart having a PatentForamen Ovale;

FIG. 2 illustrates a perspective view of an embodiment of a medicalsystem according to the present invention;

FIG. 3A illustrates an embodiment of a closure device according to thepresent invention;

FIG. 3B illustrates an embodiment of a closure device in a non-deployedorientation according to the present invention;

FIG. 3C illustrates a cut-out view of a portion of a closure deviceaccording to the present invention;

FIG. 4 illustrates an embodiment of a delivery device according to thepresent invention;

FIGS. 5A-5C illustrate cross-sectional views of a delivery deviceaccording to the present invention;

FIG. 6 illustrates an exploded view of a delivery device according tothe present invention;

FIG. 7 illustrates an embodiment of a coupling system according to thepresent invention;

FIG. 8A illustrates an embodiment of a closure device being partiallydeployed in an internal tissue opening;

FIG. 8B illustrates an embodiment of a delivery device in an orientationcorresponding to the partially deployed closure device of FIG. 8A;

FIG. 9 illustrates an embodiment of a partially deployed closure deviceaccording to the present invention;

FIG. 10A illustrates an embodiment of a closure device positioned in aninternal tissue opening;

FIG. 10B illustrates an embodiment of a delivery device in anorientation corresponding to the deployed and detached closure device ofFIG. 10A;

FIG. 11A illustrates an embodiment of a closure device having aningrowth material according to the present invention;

FIG. 11B illustrates a side view of the closure device of FIG. 11A;

FIG. 12A illustrates another embodiment of a closure device having afirst ingrowth material and a second ingrowth material;

FIG. 12B illustrates a side view of the closure device of FIG. 12A;

FIG. 13A illustrates an embodiment of a first ingrowth material forattaching to the frame of a closure device;

FIG. 13B illustrates an embodiment of a second ingrowth material forattaching to the frame of a closure device;

FIG. 14 illustrates another embodiment of a frame of a closure devicehaving clips for attaching an ingrowth material thereto;

FIG. 15 illustrates another embodiment of a frame of a closure devicewith clips and an additional beam at a distal side of the closuredevice;

FIGS. 16A and 16B illustrate engaging members of the closure device,depicting the engaging members adjacent a catheter and tissue,respectively, according to an embodiment of the present invention;

FIG. 17 illustrates another embodiment of a frame of a closure device,according to the present invention;

FIG. 18 illustrates another embodiment of a tissue growth memberattached to a closure device, according to the present invention;

FIG. 19 illustrates an embodiment for attaching the tissue growth memberto the closure device; and

FIG. 20 illustrates another embodiment of a frame of a closure device,according to the present invention.

DETAILED DESCRIPTION OF THE INVENTION

The present invention extends to medical systems, methods, and apparatusfor reducing the size of an internal tissue opening. By way ofexplanation, the devices disclosed herein can be used to treat a varietyof internal tissue openings, such as a left atrial appendage,paravalvular leaks, PDA's, and VSD's, for example. Although, forpurposes of simplicity, frequent reference is made herein to reducingthe size of or closing an opening in heart tissue known as PatentForamen Ovale (“PFO”). Accordingly, it will be understood thatreferences to PFO openings are not limiting of the invention.

In the following description, numerous specific details are set forth toassist in providing an understanding of the present invention. In otherinstances, aspects of delivery and/or closure devices, or medicaldevices in general have not been described in particular detail in orderto avoid unnecessarily obscuring the present invention. In addition, itis understood that the drawings are diagrammatic and schematicrepresentations of certain embodiments of the invention, and are notlimiting of the present invention, nor are they necessarily drawn toscale.

FIG. 2 is a perspective view of a medical system 100 configured tofacilitate closure of an internal tissue opening according to oneembodiment of the present invention. In the illustrated embodiment, themedical system 100 comprises a closure device 200 adapted to reduce thesize of the internal tissue opening, and a delivery device 300 adaptedto facilitate placement and deployment of the closure device 200 withrespect to the internal tissue opening. The medical system 100 of thepresent invention can provide benefits. For example, the medical system100 can be configured to be used with different sizes, shapes and typesof internal tissue openings. Furthermore, the medical system 100 canprovide various safety measures to increase the safety and effectivenessof positioning the closure device 200. In addition, the medical system100 can be configured to provide distributed lateral force to tissue ofthe internal tissue opening.

In the illustrated embodiment, delivery device 300 comprises a handlebody 302, an actuating assembly 320 operatively associated with handlebody 302, a release assembly 340 operatively associated with the handlebody 302 and a delivery assembly 360 operatively associated with theactuating assembly 320, the release assembly 340 and the handle body302. Handle body 302 can be configured to provide a gripping surface fora user. Handle body 302 can be used to position closure device 200, aswell as facilitate deployment of the closure device 200 from thedelivery assembly 360. Actuating assembly 320 can be moved with respectto handle body 302 to selectively deploy portions of the closure device200 from the delivery assembly 360, as will be discussed more fullyherein below.

Release assembly 340 can be operatively associated with the handle body302 to enable selective detachment of closure device 200 from thedelivery assembly 360. Delivery assembly 360 can house closure device200 in a non-deployed or constrained orientation, such as illustrated inFIG. 3B for example, and facilitate deployment of closure device 200.Delivery assembly 360 can include one or more tethers 364 linked to theclosure device 200 to facilitate selective detachment of the closuredevice 200 from the delivery device 300.

With reference to FIG. 3A, the closure device 200 is illustrated in afully deployed, expanded, relaxed or non-constrained orientation.According to one embodiment of the invention, the closure device 200 canbe configured to reduce the size of an internal tissue opening so as toclose the internal tissue opening. In one embodiment, the closure device200 can reduce the size of an internal tissue opening by approximating,or in other words bringing together tissue of the internal tissueopening, such as tunnel tissue in a PFO. The closure device 200 canapproximate tissue by applying lateral force to tissue of the internaltissue opening, as will be discussed more fully herein after. Also, theclosure device 200 can be configured to enable a user to estimate theposition and/or orientation of the closure device 200 with respect to aninternal tissue opening, during and after positioning of the closuredevice 200 in the internal tissue opening.

According to one embodiment of the invention, the closure device 200 canbe a non-tubular stent. The closure device 200 can be configured toassume a substantially flat configuration, or in other words beconfigured to be substantially planar, such as illustrated in FIGS. 3Aand 11B for example. Furthermore, the closure device 200 can beconfigured to resist movement out of plane, such as plane 260 of FIG.11B. However, the closure device 200 may bend out of plane whenpositioned in a tissue opening. In the embodiment shown, the non-tubularconfiguration of the closure device 200 is maintained both when inconstrained within a delivery device as well as when deployed in atissue structure such as a PFO.

The closure device 200 according to one embodiment of the invention hasmany advantages. For example, the closure device 200 can be configuredto be reliable and compliant. The configuration of the closure device200 can enable the closure device 200 to be movable between anon-deployed orientation and a deployed orientation without causingfailure or plastic deformation of the closure device 200. The closuredevice 200 can be used to close various types, shapes and sizes ofinternal tissue openings. Furthermore, the closure device 200 canaccommodate for a range of PFO tunnel lengths, for example. Also, theclosure device 200 can be partially or fully deployed from or receivedback into the delivery device 300. Closure device 200 can be configuredto substantially conform to the size and shape of a tissue opening. Forexample, the undulations on the distal and proximal anchors can enablethe anchors to substantially, or to a certain degree, conform to theanatomy of a tissue opening.

Generally, the closure device 200 can have a substantially flat aspecthaving a length and height greater than its depth or depth thickness.For example, in one embodiment, the closure device 200 has an overalllength of 22 mm, a height of 7.5 mm and a depth thickness of 0.4 mm.According to one embodiment of the present invention, when the closuredevice 200 is in the relaxed or completely expanded orientation, asillustrated in FIG. 3A, the distance between the opposing ends of theproximal anchor 218 can be about 22 mm, the distance between the mostproximal attachment member 240 of the body portion 202 and the mostdistal indicator 220 of the body portion 202 can be about 7.5 mm, andthe depth thickness, designated as DT in FIG. 11B, of the closure device200 can be about 0.4 mm.

Furthermore, the majority of segments comprising the closure device 200can have a thickness or width that is substantially less than the depththickness of the segments. The closure device 200 can resist out ofplane movement due to the size and configuration of the segments. Forexample, the closure device 200 can be configured to assume asubstantially flat configuration in a first plane. The configuration ofthe segments, for example the segments having a certain depth thickness,can facilitate the closure device 200 resisting movement out of thefirst plane in a manner similar to an I beam resisting bending in thedirection of the web of the beam. The first plane can be plane 260 asillustrated in FIG. 11B.

Also, the closure device 200, according to one embodiment of theinvention, can have a unitary construction. For example, the closuredevice 200 can be cut from a single piece of material, such as cut by alaser, thereby removing the need to assemble or join different segmentstogether. A unitary construction can provide advantages, such as ease ofmanufacturing and reliability. For example, assembly is not required fora closure device having a unitary construction. Also, a closure devicehaving a unitary construction may not include distinct elements orsegments which require joining by joints, thereby reducing a likelihoodof failure. The closure device 200 can be made from a super-elasticmaterial, such as a super-elastic metal or a super-elastic polymer.Furthermore, the closure device 200 can be made from NiTiNol, stainlesssteel alloys, magnesium alloys, and polymers including bio-resorbablepolymers.

In some embodiments according to the present invention, the closuredevice can be formed by utilizing a pressurized stream of water, such asa water jet, to remove material from a piece of material to form theclosure device. Furthermore, it is contemplated that the closure devicecan be formed by utilizing one or more of the following: die casting,chemical etching, photolithography, electrical discharge machining, orother manufacturing techniques. It is contemplated that the closuredevice can be formed through use of a mill or some other type of deviceadapted to remove material to form a desired shape.

It will be appreciated by one of ordinary skill in the art in view ofthe disclosure provided herein that the closure device 200 can comprisemultiple segments joined together by a known joining process, such as byan adhesive, by interference fits, crimping, by fasteners, or a weld, orsome combination thereof. For example, in one embodiment, the closuredevice can include multiple segments joined together by various welds toform a closure device according to the present invention. In otherembodiments, the segments can be joined together by a plurality ofmeans, such as by the combination of welding, fasteners, and/oradhesives. The segments can be a wire or multiple joined or rolled wirescrimped together or joined by a joining process to form the closuredevice 200.

In the illustrated embodiment, the closure device 200 includes a bodyportion 202, a first anchor 204 operatively associated with the bodyportion 202 and a second anchor 206 operatively associated with the bodyportion 202. The body portion 202 can be configured to facilitateapplication of lateral force against tissue of an internal tissueopening. Also, the body portion 202 can be configured to enable theclosure device 200 be movable between a non-deployed and deployedorientation. For example, the closure device 200 can be configured to beself-expanding from the constrained or non-deployed orientation, asillustrated in FIG. 3B for example, to the relaxed orientation, asillustrated in FIG. 3A. In other words, the closure device 200 can havea preferential orientation, such that movement of the closure device 200from a first orientation to a second orientation can create internalstresses in the closure device 200. These internal stresses can serve tobias the closure device 200 to the first orientation. For example, inone embodiment, the closure device 200 can have a preferentialorientation of the relaxed or fully deployed orientation as illustratedin FIG. 3A. In this embodiment, movement of the closure device 200 to aconstrained orientation, such as illustrated in FIG. 3B for example, cancreate internal stresses in the closure device 200, thereby creating inthe closure device 200 a bias to return to the relaxed orientation.

In the illustrated embodiment, body portion 202 includes one or morecells 208 defined by a plurality of segments 210. The body portion 202can include one or more apertures. In one embodiment, an aperture isdefined by the cell 208, or in other words by the plurality of segments210. In one embodiment, segment 210 can be a strut or a body supportsegment. Cells 208 can be distinct, or can be at least partially definedby a common segment. For example, cell 208A, as the distal most cell,and cell 208C, as the proximal most cell of body portion 202, aredistinct and defined by distinct segments 210 with respect to eachother. However, cell 208B is partially defined by a segment 210C whichalso defines a portion of cell 208A. Similarly, cell 208B is partiallydefined by a segment 210G which also partially defines cell 208C.Likewise, cell 208D shares a segment 210D with cell 208A and shares asegment 210H with cell 208C.

Segments 210 can be shaped and configured to have a substantiallyuniform stress at any given point along a certain length, when thesegment 210 is deflected. For example, segment 210A can include a firstportion 230 having a width or thickness greater than a second portion232, wherein the width or thickness decreases from the first portion 230to the second portion 232, or in other words is tapered, in a mannerwhich provides for substantially uniform stress levels along the certainlength. In other embodiments, segments can have a substantially constantwidth along their length.

FIG. 3C is a cut-out view of a portion of the closure device 200,including the first portion 230 and the second portion 232 of segment210A. In the illustrated embodiment, the width or thickness of thesegment 210A varies along the portion of the segment 210A from thelocation where segment 210A extends from the portion 254 which joinssegment 210A to segment 210C to the intermediate portion 234. As theclosure device 200 moves between an expanded or otherwise relatedorientation and a constrained or otherwise collapsed orientation, thesegments 210 are deflected, with the highest levels of stress in thesegment 210 being concentrated at the joining portion 254 and decreasingtowards the intermediate portion 234. The segments 210 can be configuredin a manner so as to have a substantially equal stress level along thelength of the segment 210 between the joining portion 254 and theintermediate portion 234. The uniform stress level can be accomplishedby having the width of the segment 210 vary from the first portion 230to the second portion 232 in a calculated manner. In one embodiment, thewidth of the first portion 230 of the segment can be about 0.1 mm andthe taper to a width of about 0.05 mm at the second portion 232 of thesegment.

In other embodiments, the uniform stress level can be accomplished byutilizing a gradient of material having varying properties. In otherembodiments, the segment 210 can have varying widths along its lengthand comprise a gradient of material sufficient to achieve asubstantially uniform stress level between the first portion 230 and thesecond portion 232 of the segment. In the illustrated embodiment, thefirst portion is adjacent the joining portion 254 and the second portionis adjacent the intermediate portion 234. In yet additional embodiments,the joints of the interconnecting segments can include a biasing member,such as a spring, thereby enabling the segments to move relative to eachother to collapse or expand the closure device 200. Furthermore, thebiasing member of the joint can cause the segments to have apreferential orientation with respect to each other.

With continued reference to FIG. 3A, segments 210 can also be configuredto have a rectangular cross-section. In other embodiments, segments 210can have an oval shaped cross section. In yet another embodiment,sections 210 can have a round or rounded cross section. Furthermore, inone embodiment, the ratio, or aspect ratio, of the thickness or width tothe depth thickness of the first and second portions 230, 232 can rangebetween at least about 1:2 to about 1:20. In one embodiment, the aspectratio of the width to the depth thickness of the first portion 230 canbe at least 1:2 and the ratio of the width to the depth thickness of thesecond portion 232 can be at least 1:4. In an alternative embodiment,the aspect ratio of the first portion 230 can be about 1:4 and theaspect ratio of the second portion 232 can be about 1:8. In this manner,the closure device 200 can substantially resist out of plane movement,while allowing in-plane movement during reorientation of variousportions of the closure device 200.

Segments 210 can be configured to be compliant. Compliancy of segments210 can enable cells 208, and thus the body portion 202, to be orientedin various orientations. For example, body portion 202 can be oriented,or in other words moved, between a non-deployed orientation, such asillustrated in FIG. 3B, and a fully deployed orientation, such asillustrated in FIG. 3A. The compliancy of segments 210 can facilitatethe accommodation by the closure device 200 of a variety of types,shapes and sizes of internal tissue openings. For example, the size andconfiguration of the first and second anchors 204, 206 and the bodyportion 202 can enable the closure device 200 to accommodate varyingsizes, shapes and types of internal tissue openings. In oneimplementation, the first anchor 204 can engage wall tissue of aninternal tissue opening and the second anchor 206 can engage only thetunnel tissue of the internal tissue opening to approximate tissue. Inan alternative implementation where the internal tissue opening has ashorter tunnel length, the second anchor 206 can engage the tunneltissue and an opposing wall of the internal tissue opening toapproximate tissue.

Segments 210 can include an intermediate portion 234 configured tofacilitate securement of ingrowth materials to the closure device 200,or can be used as an indicator 220 to facilitate estimation of theposition of the closure device 200 with respect to an internal tissueopening. Furthermore, intermediate portion 234 can be configured tofacilitate measuring of a characteristic of an internal tissue opening.In one embodiment, intermediate portion 234 can include one or moreapertures. The apertures can be configured to receive a securingelement, such as a thread, therethrough to facilitate securing aningrowth material to the closure device 200. Intermediate portion 234can be configured to be stiffer or more rigid than first portion 230,second portion 232, or both. A stiffer intermediate portion 234 canincrease the reliability of segments 210.

In another embodiment, the intermediate portion 234 can include anindicator 220, such as a dense metallic rivet or concentration of densematerial, for use in estimating the orientation and/or position of theclosure device 200. Understanding of the orientation and/or position ofthe closure device 200 can facilitate estimating a physicalcharacteristic of an internal tissue opening and/or the relativeposition of the closure device 200 with respect to the internal tissueopening. For example, if the distance between the indicators 220 isknown, a practitioner can estimate a physical characteristic, such asthe opening or tunnel width, by determining the new distance between theindicators 220 when the closure device 200 is positioned in the tissueopening. Similarly, indicators 220 can be positioned on the first andsecond anchors 04, 206. The indicators 220 can be configured andarranged on the closure device 200 such that when the first anchor 204is deployed the indicators 220 are substantially aligned. In thismanner, a practitioner can estimate whether the first anchor 204 hasfully deployed.

In some cases, it may be difficult to view the closure device 200 in theevent the closure device 200 is at a skewed angle with respect to theviewing plane, such as a fluoroscope. When the closure device 200 isskewed in this manner, it can be difficult to determine accurately thedistance of interest. However, when various distances between indicatorsis known, a user can use the known distances to calculate the distancesof interest by using geometry.

In one embodiment, segments 210 along a similar or common lateral planecan have substantially equal lengths. Substantially equal lengths ofsegments 210 in this manner can enable body portion 202 to be movedbetween the non-deployed and deployed orientation without failure of thesegments 210. For example, in one embodiment, segments 210A and 210Bhave substantially the same length, segments 210E, 210C, 210D, and 210Khave substantially the same length, segments 210F, 210G, 210H and 210Lhave substantially the same length, and segments 210I and 210J havesubstantially the same length. In this configuration, body portion 202can be collapsed or oriented into the non-deployed orientation, asillustrated in FIG. 3B, without causing damage to the body portion 202of closure device.

The closure device 200 can be configured to have a preferentialorientation of the fully deployed orientation as illustrated in FIG. 3A.As the closure device 200 is deployed from the delivery device 300, theconfiguration of closure device 200 can cause the closure device 200 topreferentially move toward the fully deployed orientation. Thus, as theclosure device 200 is deployed in an internal tissue opening, thepreferential orientation of the closure device 200 can cause the closuredevice 200 to apply lateral force to the tissue of the internal tissueopening. In other words, the body portion 202, first anchor 204 and thesecond anchor 206 are deflected by an applied force in order to reorientthe closure device 200 from the fully deployed orientation to anon-deployed orientation, for example. In this manner, the closuredevice 200, because of the deflection of the body portion 202, firstanchor 204 and the second anchor 206, will have tendency to return tothe fully deployed orientation. When the closure device 200 ispositioned in an internal tissue opening, the deflected body portion202, first anchor 204 and the second anchor 206 can have a tendency toapply a lateral force to tissue of the opening as the closure device 200attempts to return to the fully deployed orientation.

Body portion 202 can be operatively associated with the first anchor 204and the second anchor 206. First and second anchors 204, 206 can beconfigured to move between a deployed and non-deployed orientation.First and second anchors 204, 206 can be configured to apply lateralforce to tissue of an internal tissue opening, and to engage and/orcontact a portion of wall tissue and/or tunnel tissue of an internaltissue opening. In one embodiment, the first anchor 204 can be a leftatrial anchor, and the second anchor 206 can be a right atrial anchor.

In the illustrated embodiment, the first anchor 204 can include a firstanchor segment 212 and an opposing second anchor segment 214. Likewise,the second anchor 206 can include a first anchor member 216 and anopposing second anchor member 218. The first anchor segment 212 can beconfigured to move relative to the second anchor segment 214. Likewise,the first anchor member 216 can be configured to move relative to thesecond anchor member 218. In this manner, the closure device 200 canaccommodate for a variety of types, shapes and sizes of internal tissueopenings. The first anchor segment 212 and the second anchor segment 214can be configured to be substantially similar in size, shape andconfiguration. As such, reference to the configuration and/or functionof one of the first or second anchor segments can apply to the otheranchor segment. In one embodiment of the invention, the first anchor 204and/or the second anchor 206 can include one or more undulations. Theundulations can facilitate reorienting or movement of the anchors withrespect to the body portion 202, for example, from a deployed to anon-deployed configuration. Furthermore, the undulations can facilitatethe anchor substantially conforming to the anatomy of the tissueopening.

The first anchor segment 212 can include a distal end 224 and a proximalend 226. The first anchor segment 212 can be defined by various segmentsand can include reinforced segments 228 and one or more engaging members222. For example, in the illustrated embodiment, the first anchorsegment 212 is at least partially defined by segment 210K of cell 208D.The engaging members 222 can be microposts or tines configured tocontact and/or engage tissue. The engaging members 222 can include asharp tip or can be blunt. The engaging members 222 can be configured toprovide a degree of surface texture in order to increase engagement ofthe first anchor 204 with tissue.

The first anchor segment 212 can be configured to be moved between anon-deployed orientation, as illustrated in FIG. 3B, and a fullydeployed orientation, as illustrated in FIG. 3A. The first anchorsegment 212 can be configured such that the distance from the proximalend 226 to the distal end 224 of the segment which includes the engagingmembers 222 is substantially equal to the distance from the proximal end226 to the distal end 224 of the segment which includes the reinforcedsegments 228 and segment 210K. The second anchor segment 214 can beconfigured similar to the first anchor segment 212.

First anchor segment 212 can be configured to define a closed periphery.For example, first anchor segment 212 can include the reinforced segment228 extending from the body portion 202 to the segment having theengaging members 222 which is connected to segments 210K, 210L to definea closed periphery with segment 210K. Furthermore, two reinforcedsegments 228 can extend from the joining portion 254 of the body portion202 and join together near the distal end 224 of the first anchor 204.As such, there are multiple anchor portions extending from the bodyportion 202. In this manner, anchors of the present invention arereinforced to provide greater rigidity and strength to facilitatestabilization and maintenance of the closure device 200 within a tissuestructure.

First anchor member 216 can include a distal end 236 and a proximal end238. The first anchor member 216 can be defined by various segments andcan include one or more engaging members 222. For example, in theillustrated embodiment, the first anchor member 216 is at leastpartially defined by segment 210L of cell 208D. The engaging members 222can be microposts or tines configured to contact and/or engage tissue.The engaging members 222 can include a sharp tip or can be blunt. Theengaging members 222 can be configured to provide a degree of surfacetexture to increase engagement of the second anchor 206 with tissue.

It will be understood by one of ordinary skill in the art in view of thedisclosure provided herein that the engaging members 222 can vary insize and shape, and can be positioned at various locations on theclosure device 200. In alternative embodiments, one or more engagingmembers can extend out of plane of the closure device so as to contacttissue which is perpendicular, for example, to the substantially flatplane, such as plane 260 of FIG. 11B, of the closure device 200.

The first anchor member 216 can be configured to be moved between anon-deployed orientation, as illustrated in FIG. 3B, and a fullydeployed orientation, as illustrated in FIG. 3A. The first anchor member216 can be configured such that the distance from the proximal end 238to the distal end 236 of the segment which includes the engaging members222 is substantially equal to the distance from the proximal end 238 tothe distal end 236 of the segment which includes segment 210L. In thismanner, first anchor member 216 can be detachably coupled to thedelivery device 300 when in a non-deployed orientation inside thedelivery device 300 as illustrated in FIG. 3B. The second anchor member218 can be configured similar to the first anchor member 216.

The first anchor segment 212 can also include a first portion 256 and asecond portion 258 configured to facilitate engagement of the internaltissue opening. For example, first anchor segment 212 can be configuredto include one or more undulations causing the first portion 256 to bepositioned in close proximity with second portion 258. In this manner,as tissue is positioned between the first and second portions 256, 258,the configuration of the first anchor segment 212 can engage, or to somedegree, pinch the tissue therebetween to facilitate maintenance of theposition of the closure device 200 with respect to the tissue opening.

The closure device 200 can also include attachment members 240 for usein detachably linking the closure device 200 to the delivery device 300,as will be discussed more fully herein after. The attachment members 240can include an aperture 242 for use in facilitating the linking of theclosure device 200 to the delivery device 300.

FIG. 3B illustrates the closure device 200 in a non-deployed orconstrained orientation. The configuration of the body portion 202, andthe first and second anchors 204, 206 enables the closure device 200 bereoriented from the fully deployed and preferential orientation, asillustrated in FIG. 3A, to the non-deployed or collapsed orientation asillustrated. In the collapsed or non-deployed orientation, the firstanchor 204 extends distally and the second anchor 206 extendsproximally, with the attachment members 240 being the proximal mostportions of the second anchor 206 and the body portion 202.

In the illustrated embodiment, the closure device 200 is positionedinside of a delivery portion 366 of the delivery device 300. Theconfiguration of the closure device 200 can cause portions of theclosure device to apply force to the wall of the delivery portion 366due to the preferential orientation of the closure device 200. Theclosure device 200 is configured to be received into and deployable fromthe delivery portion 366.

Delivery Device 300

FIG. 4 illustrates one embodiment of the delivery device 300. In theillustrated embodiment, the delivery assembly 360 includes a catheter362 having a delivery portion 366, and a plurality of tethers 364 atleast partially housed by the catheter 362. The tethers 364 can beconfigured to facilitate selective detachment of the closure device 200from the delivery device 300. The delivery portion 366 can be configuredto receive the closure device 200 therein. The catheter 362 can becoupled to the actuating assembly 320, such that movement of theactuating assembly 320 can cause movement of the catheter 362.

In the illustrated embodiment, the actuating assembly 320 includes afirst member 322 operatively associated with the handle body 302, asecond member 324 operatively associated with the first member 322 andthe handle body 302, and a knob 338 linked to the first member 322. Theactuating assembly 320 can be utilized by a user to selectively deploythe closure device 200 from the catheter 362.

The handle body 302 can include indicia 304 to enable a user to estimatethe degree of deployment of the closure device 200 from the deliverydevice 300, as well as predict detachment of the closure device 200 fromthe delivery device 300. For example, indicia 304 can include deploymentindicia 306 and release indicia 308. Deployment indicia 306 can beutilized to enable a user to estimate the degree of deployment of theclosure device 200 from the catheter 362, and the release indicia 308can be utilized to predict the detachment of the closure device 200 fromthe delivery device 300. The handle body 302 can also include a releasepin groove 310. The release pin groove 310 can be operatively associatedwith the release assembly 340 to facilitate the selective detachment ofthe closure device 200 from the tethers 364.

According to one embodiment of the invention, the release assembly 340can include a biasing member 342 operatively associated with the handlebody 302 to facilitate detachment of the closure device 200. A releaseknob 346 can be provided to manipulate the position of biasing member342 in order to release or detach the closure device 200. In oneembodiment, the release knob 346 is coupled to the biasing member 342,such that movement of the release knob 346 can cause movement of thebiasing member 342. The biasing member 342 can include a release pin 344configured to be received in, influenced by and movable in the releasepin groove 310. In this manner, release pin groove 310 can restrict, andthereby influence the movement of the biasing member 342 with respect tothe handle body 302.

The biasing member 342 is configured to interact with the handle body302 such that when the release pin 344 is positioned in a terminatingportion of the release pin groove 310, as illustrated in FIG. 4, thebiasing member 342 is biased in the proximal direction with respect tothe handle body 302. In this manner, the release pin 344 can be movedfrom the terminating portion of the release pin groove 310, asillustrated in FIG. 4, to the opposing terminating portion of therelease pin groove 310 adjacent the release indicia 308B by applyingforce to the biasing member 342 through the release knob 346 in thedistal direction, rotating the release knob 346 and then moving therelease knob 346 in the proximal direction to release the closure device200, as illustrated in FIG. 10B.

FIG. 5A is a cross-sectional view of the distal end of the catheter 362.In the illustrated embodiment, the catheter 362 includes a deliveryportion 366 for use in positioning the catheter 362. The catheter 362can be made from a resilient material having sufficient axial stiffnessto allow a practitioner to position the catheter 362 with respect to aninternal tissue opening, and sufficient rotational stiffness to allow apractitioner to rotate the catheter 362 by rotating the handle body 302.

In one embodiment, the catheter 362 comprises a braided polyimide. Inother embodiments, the catheter 362 can be made from a material having asufficient axial stiffness, such as a braid reinforced polymer, axiallyreinforced polymer, metal reinforced polymer, carbon reinforced polymer,or some other type of axially stiff material. The delivery portion 366can be made from a thermoplastic elastomer, such as PEBAX.RTM. In otherembodiments, the delivery portion or tip portion 366 can be made from amaterial having sufficient flexible properties, such as a polymericmaterial. In other embodiments, the delivery portion 366 can include acombination of materials, such as metallic materials and polymericmaterials.

The delivery portion 366 can define a lumen 368 to facilitate placementof the catheter 362. For example, a guide wire can be received in thelumen 368 to guide the catheter 362 to a desired location. In thismanner, the closure device 200 can be located proximate to the internaltissue opening in a quick and efficient manner. Furthermore, thedelivery portion 366 can be shaped, such as including a bend, in orderto facilitate placement of the delivery portion 366 through a PFO, forexample. In one embodiment of the invention, the catheter 362 can beconsidered a rapid exchange catheter wherein the delivery or tip portion366 enables a guide wire to be linked to the catheter 362 in a quick andefficient manner for placement of the catheter 362.

The catheter 362 and delivery portion 366 can be configured to at leastpartially house tethers 364 in a lumen which is distinct and separatefrom lumen 368. For example, lumen 368 can be in a spaced apart,non-coaxial arrangement from the lumen which houses tethers 364, suchthat a guide wire can be received through lumen 368 without beingintroduced into the lumen or space in which the tethers 364 are housed.In this manner, a user can introduce a guide wire into the lumen 368 atthe distal end of the catheter 362, rather than the lumen which at leastpartially houses the tethers 364 which would require the guide wire tobe introduced into the lumen at the proximal end of the catheter 362. Inalternative embodiments, the lumen 368 configured to receive the guidewire therein can be positioned inside the lumen which houses the tethers364. In this embodiment, lumen 368 would include an opening and an exitat the distal end of the catheter 362 in order to facilitate the quickplacement of a guide wire through the lumen 368.

In one embodiment, catheter 362 can include a rounded cross-section andthe delivery portion 366 can include a rectangular cross-section. Therectangular cross-section of the delivery portion 366 can facilitateproper deployment of the closure device 200 from the delivery device300, as well as facilitate the closure device 200 being reintroducedback into the delivery portion 366. The rectangular cross-section of thedelivery portion 366 can be sized to orient the tethers 364 next to eachother in a linear fashion. In this manner, the likelihood that thetethers 364 cross each other upon reintroduction of the closure device200 into the delivery portion 366 can be reduced.

In one embodiment of the invention, tethers 364 includes three tethers364A-C, each tether 364 being sized and configured to attach to and/oraccommodate therein an attachment member 240 of the closure device 200.One example of a tether is a line or hollow tube coupled to the handlebody 302. The tether 364 can comprise a flexible, hollow shaft havingsufficient stiffness such that as actuating assembly 320 moves thecatheter 362 proximally with respect to the handle body 302, the closuredevice 200 is forced out of the delivery portion 366. Likewise, thetether 364 can be configured to pull the closure device 200 back intothe delivery portion 366 as the actuating assembly 320 is moved distallywith respect to the handle body 302.

In one embodiment, the tether 364 can be a coil of stainless steelcovered by a heatshrunk tubing to give the coil a degree of tensilestrength and rigidity. In an alternative embodiment, the tether 364 canbe a polymeric tube. In yet an additional embodiment, the tether 364 canbe a combination of polymeric materials and metallic materials. In someembodiments, an additional heatshrunk tubing covers a proximal segmentof the three tethers 364A-C. The heatshrunk covering can increase thecolumn strength of the tether 364, which can enable the tethers 364 toassist with deployment and reintroduction of the closure device 200 fromand into the delivery portion 366. The tethers 364 can have a distal tipconfigured to correspond to the shape and size of the attachment members240 of the closure device, such that the attachment member 240 can bereceived into the distal tip of the tether 364, as illustrated in FIG.7.

Tethers 364 can be made from a material having sufficient flexibility tosubstantially prevent distortion or otherwise influence the orientationof the closure device 200 when the closure device is deployed from thecatheter 362, yet have sufficient axial strength to facilitatedeployment of the closure device 200 when the catheter 362 is movedproximally with respect to the closure device 200. The tethers 364 canhave a lumen extending therethrough of sufficient size and configurationto enable a plurality of wires 378 to be housed and movable therein.

FIGS. 5B-5C are cross-sectional views illustrating the delivery assembly360 in association with the actuating assembly 320. However, forsimplicity, FIG. 5B does not include the biasing member 342 andassociated release knob 346, and FIG. 5C illustrates details about theinteraction between the delivery assembly 360 and the actuating assembly320 without illustrating the first member 322 and details about thehandle body 302 and the second member 324. In the illustratedembodiment, the proximal end of the catheter 362 is coupled to thedistal end of the second member 324. In this manner, movement of thesecond member 324 can cause a corresponding movement in the catheter362. For example, as the second member 324 moves proximally with respectto the handle body 302, so also does the catheter 362 move proximallywith respect to the handle body 302.

According to one embodiment of the invention, the tethers 364 can extendfrom the delivery portion 366, through the catheter 362 and the secondmember 324 and are coupled to the handle body 302. The tethers 364 canbe coupled to the handle body 302 by, for example, an intermediatemember 376. The tethers 364 can be covered with a first and secondhousing 370, 372 to provide a degree of rigidity to the portions of thetethers 364 located inside of the handle body 302 and the second member324. For example, in one embodiment, the first housing 370 comprises arigid, hollow, metal rod configured to house the three tethers 364A-Ctherein. The first housing 370 can extend from the intermediate member376, which facilitates securement of the tethers 364 to the handle body302, and terminate at some point beyond the handle body 302.

In the illustrated embodiment, the second housing 372 can extend fromthe distal end of the first housing 370 and extend into the catheter362. The second housing 372 can comprise a resilient material configuredto resist axial stretching while allowing a degree of bending. In oneembodiment, the second housing 372 comprises a coil of metal, such asstainless steel, configured to resist axial stretching, yet allow adegree of bending. The second housing 372 can allow a practitioner tobend a portion of the catheter 362, if needed, in order to manipulatedelivery device 300 for placement of the closure device 200. A seal 374can be provided between the first housing 372 and the second member 324in order to reduce or substantially prevent bodily fluid, which may haveentered the catheter 362, from entering the handle body 302 or otherwiseinappropriately being expelled from the delivery device 300.

In the illustrated embodiment, the second member 324 can comprise anelongate shaft defining an axial lumen 348 and a lumen 350 in fluidcommunication therewith. Lumen 350 can be configured to couple to amedical device for removal of fluid from the delivery device 300. Theaxial lumen 348 can be sized to accommodate and allow movement of thetethers 362, the first housing 370 and the second housing 372 therein.The second member 324 can include a guide 326. The guide 326 can beconfigured to cooperate with a first pin 352 and a second pin 354 toinfluence movement of the second member 324 with respect to the handlebody 302, as will be discussed more fully herein below.

In the illustrated embodiment, the first member 322 comprises a hollowelongate tube sized and configured to enable the second member 324 to bereceived into and moveable within the first member 322. The first member322 can be operatively associated with the handle body 302 and thesecond member 324 to facilitate deployment of the closure device 200.For example, the first member 322 is linked to the handle body 302 by athird pin 356. The third pin 356 is received in a guide 358 of the firstmember 322. The guide 358 is configured to interact with the third pin356 in order to influence the movement of the first member 322 withrespect to the handle body 302.

The first pin 352 can link the first member 322 to the second member324. When the first pin 352 links the first member 322 to the secondmember 324, the second pin 354 links the handle body 302 to the secondmember 324, and the third pin 356 links the handle body 302 to thesecond member 322, movement of the first member 322 can selectivelydeploy the closure device 200 from the delivery portion 366.

With reference to FIGS. 5A-C and 6, the association between the firstmember 322, the second member 324, the handle body 302 and the biasingmember 342 will be discussed. FIG. 6 is an exploded view of theactuating assembly 320 and the release assembly 340. In the illustratedembodiment, the second member 324 is received into the first member 322,and the first member 322 is received into the knob 338 and the handlebody 302, as illustrated in FIGS. 4 and 5B-5C.

According to one embodiment of the invention, the second member 324 caninclude a guide 326 having a first portion 326 a and a second portion326 b, which guide 326 can be defined by a slot formed on the outersurface of the second member 324. In the illustrated embodiment, thefirst portion 326 a is straight and extends along at least a portion ofthe length of the first member 324 and joins with the second portion 326b of the guide 326. The second portion 326 b can include a helicalgroove or slot that begins with and is contiguous with the first portion326 a and extends distally therefrom.

The guide 326 of the second member 324 is configured to interact withthe handle body 302 and the first member 322 to selectively retract thecatheter 362 in order to deploy the closure device 200. For example, thefirst portion 326 a of the guide 326 is configured to interact with thesecond pin 354, which is secured into the handle body 302 by means ofthreads and extend into the first portion 326 a of the guide 326. Inthis manner, the second member 324 can move laterally with respect tothe handle body 302. Thus, rotation of the handle body 302 can translateto rotation of the second member 324, and thus, the catheter 362 and thedelivery portion 366.

The second portion 326 b of the guide 326 is configured to interact withthe first pin 352, which is secured to the first member 322 by means ofthreads and extends into the second portion 326 b of the guide 326. Inthis manner, as the first member 322 is rotated, the first pin 352 willinteract with the second portion 326 b to move the second member 324 inthe proximal direction. As the second member 324 is moved in theproximal direction with respect to the handle body 302, the catheter 362moves proximally with respect to the handle body 302 thereby exposing ordeploying the closure device 200 from the delivery portion 366.

In the illustrated embodiment, the first member 322 can include a guide358 defined by a slot or groove formed in the outer surface of the firstmember 322. In the illustrated embodiment, the guide 358 can include afirst portion 358 a connected to a second portion 358 b. The firstportion 358 a of guide 358 can be straight and extend along at least aportion of the length of the first member 322, and then join and becontiguous with the second portion 358 b. The second portion 358 b ofthe guide 358 can be a helical groove that wraps around at least aportion of the outer surface of the first member 322 and extends alongat least a portion of the length of the first member 322.

As described previously, the third pin 356, which is secured to thehandle body 302 by means of threads, can extend into the guide 358 inorder to influence movement of the first member 322 with respect to thehandle body 302. For example, as the third pin 356 is positioned in themost proximal portion of the first portion 358 a, the closure device 200is completely received into and enclosed by the delivery portion 366. Asthe first member 322 is moved in the proximal direction as illustratedby the arrow in FIG. 4, the third pin 356 moves in the first portion 358a of the guide 358 to deploy the first anchor 204 of the closure device200 from the delivery portion 366.

The length of the first portion 358 a can correspond with the distancethat the first member 322, and thus the catheter 362, must move in orderto deploy the first anchor 204 of the closure device 200 from thedelivery portion 366. For example, a practitioner can move the knob 338,which is coupled to the first member 322, in the proximal direction.Movement of the knob 338 in the proximal direction can cause the thirdpin 356 to move linearly in the first portion 358 a of the guide 358. Inthis manner, the second member 324 can move correspondingly with thefirst member 322 because of the first pin 352, which links the firstmember 322 to the second member 324. As the third pin 356 is positionedin the location of the guide 358 where the first portion 358 a meetswith the second portion 358 b, the first member 322 can be rotated inorder to selectively deploy the remaining portions of the closure device200 from the delivery portion 366 of the delivery device 300.

As the first member 322 is rotated, the third pin 356 is positioned inthe second portion 358 b to influence movement of the first member 322with respect to the handle body 302, and the first pin 352, which iscoupled to the first member 322, interacts with the second portion 326 bof the guide 326 to move the second member 324 in the proximal directionwith respect to the handle body 302. Movement of the second member 324in the proximal direction in this manner can cause further deployment ofthe closure device 200 from the delivery portion 366. As will beappreciated, the knob 338 can be coupled to the first member 322 tofacilitate and enable movement of the first member 322 with respect tothe handle body 302.

The dual movement required to deploy the closure device 200 can providesome efficiency and safety advantages. For example, a practitioner canmove the knob 338 in a first direction (i.e., proximally in a linearfashion) to deploy the first anchor 204 from the delivery portion 366.Thereafter, the practitioner can move the handle body 302 to positionthe first anchor 204 against the wall tissue of an internal tissueopening, such as against the left atrial wall of a heart, for example.Once the first anchor 204 is positioned against the wall, thepractitioner can move the knob 338 in a second direction (i.e., rotatethe knob) to further deploy the closure device 200 from the deliveryportion 366. The dual movement enables a user to predict the deploymentof the closure device 200 to reduce the risk of premature deployment ofthe closure device.

It will be understood by one of ordinary skill in the art in view of thedisclosure provided herein that other means of controlling movement ofone member with respect to the other, such as the first member withrespect to the second member, can be utilized without departing from thescope and spirit of the invention. For example, a structure configuredto substantially restrict or control movement of the first element withrespect to the second element and/or handle body can be utilized. In oneembodiment, the structure can include a cam and a follower. In analternative embodiment, the structure can include a slider.

The release assembly 340 can be configured to be received in theproximal end of the handle body 302. The release assembly 340 can beconfigured to provide additional safety features for the practitionerand patient by reducing the risk of premature detachment of the closuredevice 200 before it is positioned appropriately in an internal tissueopening. For example, a practitioner using the medical system 100 of thepresent invention can manipulate the actuating assembly 320 to deploythe closure device 200 for positioning in an internal tissue opening. Inorder to deploy a first portion of the closure device 200, a user canmove the knob 338, and thus the first member 322, in the proximaldirection with a first movement, which is a linear movement, then deploythe remaining portions of the closure device 200 by a rotationalmovement. Once the closure device 200 is deployed, the practitioner canbe required to move their hands in order to utilize the release assembly340 to release the closure device 200 from the delivery device 300.

In the illustrated embodiment the release assembly 340 can include arelease knob 346 coupled to a biasing member 342, which is received intothe proximal end of the handle body 302. The biasing member 342 can beconfigured to include a plurality of slots 318 configured and arrangedto act similar to a spring. The slots 318 can be configured and arrangedin the biasing member 342 to enable at least a portion of the biasingmember 342 to be compressed. Compression of the biasing member 342 cancause the release pin 344 to move toward the distal end of the biasingmember 342.

The biasing member 342 can be configured such that when biasing member342 is positioned in the handle body 302, the biasing member 342naturally tends to maintain its position with the release pin 344 in therelease pin groove 310 as illustrated in FIG. 4. As force is applied tothe release knob 346 in the distal direction (i.e., compress the biasingmember 342), the release pin 344 can be moved out of a terminatingportion of the release pin groove 310 and rotated and moved into aproximal terminating portion of the release pin groove 310 to releasethe closure device 200 from the delivery device 300.

The closure device 200 is released from the delivery device 300 bymoving a plurality of wires 378 which are housed by a tether 364 andcoupled to the biasing member 342. Illustrated in FIG. 7 is across-sectional view of attachment member 240 of the closure device 200received into a tether 364 and coupled by first and second wires 378 a,378 b. In the illustrated embodiment, a second wire 378 b can extendthrough and out of the tether 364 and form a loop. The loop can extendthrough an aperture 242 of the attachment member 240 of the closuredevice 200. With the loop of second wire 378 b positioned through theaperture 242 of the attachment member 240, a first wire 378 a, whichextends through and out of the tether 364, can extend through the loopof the second wire 378 b to form a locking feature. When the first wire378 a extends sufficiently through the loop of the second wire 378 b,the closure device 200 can remain coupled to the delivery device 300until the first wire 378 a is pulled through the loop of the second wire378 b, and the second wire 378 b is pulled out of the aperture 242 ofthe attachment member 240.

The first wire 378 a and the second wire 378 b can be attached at theirproximal ends to the biasing member 342. In this manner, movement of thebiasing member 342 in the proximal direction can cause movement of thewires 378 also in the proximal direction. In one embodiment, the wires378 can be coupled to the biasing member 342 such that movement of thebiasing member 342 will cause the first wire 378 a to move a distancesufficient to be removed from the loop of second wire 378 b before thesecond wire 378 b is moved by the biasing member 342. The wire 378 cancomprise a metallic wire, such as a NiTiNol wire. The wire 378 can alsoinclude a stainless steel wire or some other type of metal or stiffpolymer. The wires 378 can be made from a material having a sufficienttensile strength to secure the closure device 200 to the tethers 364without causing the wires 378 to fail or substantially deform. In oneembodiment of the invention, the wire 378B can include a stainless stealwire and wire 378A can include a NiTiNol wire.

Other types and configurations of biasing members can be utilizedwithout departing from the scope and spirit of the invention. Forexample, in one embodiment, the release assembly can include a rotatingmember coupled to the securing elements. In this embodiment, rotation ofthe rotating member can cause the securing elements to wind around therotating member thereby causing the distal ends of the securing elementsto move proximally with respect to the handle body.

The method of use of the medical system 100 will now be described withreference to a particular internal tissue opening, namely a PFO. FIG. 8a illustrates the positioning of the catheter 362 through the tunnel 58of a PFO with the first anchor 204 of the closure device 200 deployed.The medical system 100 is utilized to close an internal tissue openingby positioning the catheter 362 through an internal tissue opening andmoving the first member 322 by a first movement (i.e., linearly) in theproximal direction to deploy the first anchor 204 of the closure device200. After the first anchor 204 of the closure device 200 is deployed,the delivery device 300 can be moved in the proximal direction in orderto seat the first anchor 204 against the wall of the tissue opening orotherwise engage the wall of the internal tissue opening, as illustratedin FIG. 9. This can be done by moving the handle body 302 in theproximal direction.

After the first anchor 204 has been positioned against the wall of theinternal tissue opening, the knob 338, and thus the first member 322,can moved by a second movement, or in other words, rotated to deployadditional portions of the closure device 200 as illustrated in FIG. 9.After the closure device 200 has been fully deployed and conforms to theanatomy of the internal tissue opening, the release assembly 340 can beactuated to selectively detach the delivery device 300 from the closuredevice 200 as illustrated in FIGS. 10 a and 10 b.

The release assembly 340 can be actuated by moving the biasing member342 distally with respect to the handle body 302, then rotating thebiasing member with respect to the handle body 302, and then movedproximally with respect to the handle body 302. In this manner, closuredevice 200 substantially conforms to the anatomy of the internal tissueopening. As noted previously, the configuration of the closure device200 is such that when positioned in the internal tissue opening asillustrated, the members of the closure device 200 apply lateral forceto the tissue of the internal tissue opening, such as the tunnel 58 ofthe PFO, to approximate tissue of the PFO for closure.

FIG. 11A illustrates one embodiment of a closure device 200 that caninclude a member 250, such as an ingrowth material. The member 250 canbe configured to induce tissue growth. The member 250 can be fixed tothe closure device 200 by means of a securing element, such as a thread252. For example, the thread 252 can extend through the member 250 andthrough the apertures in the intermediate portions 234 in order tosecure the member 250 to the closure device 200. In other embodiments,the member 250 can be secured to the closure device 220 by a knownsecuring means, such as by an adhesive, a heat weld, or some other knownor hereafter developed means for securement.

The member 250 and the thread 252 can include a bio-resorbable material,such as polylactide or polyglycolide or collagen. The member 250 can besized and configured to enable the closure device 200 to be deployedfrom and received into the delivery portion 366 of the delivery device300. Furthermore, the member 250 can be configured to interact withtissue of the internal tissue opening to stimulate growth of tissue forclosure of the internal tissue opening. For example, the member 250 caninteract with the tunnel tissue 58 of a PFO in order to stimulate growthof tissue in the PFO tunnel 58.

The member 250 can be any suitable material which can or tends topromote tissue growth. Examples of such material can include a polymericmaterial, or a woven material, such as a woven metallic or biologicalmaterial. In one embodiment, the member 250 can be a piece of foam. Inalternative embodiments, the member 250 can be a piece of yarn, fabricor string, or some combination thereof. Other tissue growth promotingmembers can include a coating disposed on the closure device 200. Inother embodiments, the member 250 can be a piece of foam, braidedmaterial such as a piece of yarn or string, or fabric which has acoating disposed thereon.

The member 250 can include materials such as a piece of polyurethane orsome other biocompatible polymer, including bio-resorbable polymers. Themember 250 can also include Dacron or polymeric threaded material whichhave been woven or knitted, or formed into compressed, non-wovenfabrics. The member 250 can also include a metallic material, such as aNiTiNol, stainless steal or some other biocompatible alloy orbio-resorbable metal, such as magnesium alloy, or some combinationthereof. In one embodiment, the member 250 comprises a metallic wire.

FIG. 11B illustrates a side view of the closure device 200, andillustrates one example of the closure device having a substantiallyflat configuration. In the illustrated embodiment, the closure device200 can include a depth or depth thickness designated as DT, and a plane260 extending perpendicular into and out of the plane of the page. Inthis embodiment, the member 250 can extend beyond at least a first edge262 of the closure device 200. Furthermore, the member 250 can extendbeyond both the first edge 262 and a second edge 264 of the closuredevice 200. In this manner, member 250 can contact tissue adjacent theclosure device 200 to promote tissue growth in the tissue opening.

The member 250 can be sized and configured to extend beyond at least thefirst edge 262 of the closure device 200 a sufficient distance tocontact tissue of the tissue opening. In one embodiment, the member 250can extend beyond at least the first edge 262 a sufficient distance tocontact tissue adjacent the first edge 262, thereby causing the end ofthe member 250 which is in contact with the tissue to deflect or bend.In this manner, more surface area of the member 250 can be in contactwith tissue to thereby facilitate an increase in tissue growth. In otherembodiments, the member 250 can extend beyond both the first edge 262and the second edge 264 a sufficient distance to cause both ends of themember 250 to bend, which can result in more surface area contacting thetissue. In one embodiment, the member 250 can extend between at least0.5 mm and 5 mm beyond the first edge 262. In another embodiment, themember 250 can extend between at least 0.5 mm and 5 mm beyond the firstedge 262, and can extend between at least 0.5 mm and 5 mm beyond thesecond edge 264. Furthermore, the member 250 can have a thickness ofbetween at least 0.25 mm and 2 mm.

In addition, in some embodiments the member 250 can be configured todecrease the size of a remaining void in the tissue opening after theclosure device 200 has been positioned in the tissue opening. Member 250extending beyond the first edge 262 of the closure device 200 is anexample of the member 250 extending substantially out of plane of thesubstantially flat configuration.

FIG. 12A illustrates another embodiment of a closure device 400 with atissue growth member 450 or in-growth material. The closure device 400includes a frame 402, similar to frames depicted in the previousembodiments. As previously described, the frame 402 includes a centralportion 404 with first and second proximal anchors 406 and 408 and firstand second distal anchors 410 and 412, the proximal anchors extendingfrom a proximal portion of the central portion 404 and the distalanchors extending from a distal portion of the central portion 404 ofthe frame 402. The central portion 404 may include multiple struts 414that define a multi-cellular structure. In particular, the multiplestruts 414 may define four cells in the presently described embodiment:a first central cell 416, a second central cell 418, a proximal cell 420and a distal cell 422, each of the multiple struts 414 collectivelydefining the central portion 404 of the frame 402. As previously setforth, the frame 402 is a generally flat plane 442 (FIG. 12B) orsubstantially planar (or may be described as including or exhibiting asubstantially flat configuration) when in an expanded configuration andgenerally resists movement out of such substantially planar or flatconfiguration. Further, the frame 402 may remain in a substantially flatconfiguration when constricted within the tip portion of the catheter(not shown) or at any other deployment stage.

The tissue growth member 450 may include a first member 452 and a secondmember 454, the first member 452 being separate and distinct from thesecond member 454. The tissue growth member 450 may be attached to theframe 402 by, for example, stitching or sewing, similar to thatillustrated in the previous embodiment. In one embodiment, the tissuegrowth member 450 is configured to be positioned to extend along struts414 in the central portion 404 of the frame 402 and may include portionsextending along a portion of the first and second proximal anchors 406and 408 of the frame 402.

The tissue growth member 450 is configured to be bio-compatible andporous for inducing tissue growth therein. In one embodiment, the tissuegrowth member 450 may be foam. In another embodiment, the tissue growthmember 450 may be polyurethane. In still another embodiment, the tissuegrowth member 450 may be polyurethane foam and, more specifically, maybe reticulated polyurethane foam. Such foam may also be non-reticulatedpolyurethane foam. Other materials and structures may also be employed,as set forth in the previous embodiments. Further, the tissue growthmember can be formed, for example, from a large stock of foam and shapedas desired utilizing die cutting techniques as known in the art.

With reference to FIG. 13A, the first member 452 is depicted as being anelongated member extending between a first end 456 and a second end 458and defining a longitudinal axis 460 therethrough. Further, the firstmember 452 can include a first portion 462 and a second portion 464defining a mid portion 466 therebetween. Each of the first portion 462and second portion 464 also can include a slot 468 that extends from abottom edge 470 of the first member to about the longitudinal axis 460.Further, the first member 452 can include tapered portions 472 thattaper toward the first end 456 and the second end 458 as well as the midportion 466 of the first member 452.

With respect to FIGS. 12A and 13A, the first portion 462 of the firstmember 452 is sized and configured to be positioned along the distalstruts within the first central cell 416 and the second central cell418, the slot 468 configured to receive a center portion 424 of theframe 402. The first end 456 can be attached to a first eyelet 426 ofthe frame 402 and the mid portion 466 can be attached to a second eyelet428 of the frame 402. Similarly, the second portion 464 of the firstmember 452 is sized and configured to be positioned along proximalstruts within the first central cell 416 and the second central cell 418with the slot 468 of the second portion 464 disposed over or receivingthe center portion 424 of the frame 402. Also, similar to the firstportion 462, the second end 458 can be attached to the first eyelet 426and the mid portion 466 can be attached to the second eyelet 428. Inthis manner, the first member 452 is attached within the first andsecond central cells 416 and 418 of the frame 402 with the secondportion 464 being positioned proximal the first portion 462 of the firstmember 452. In addition, the second portion 464 of the first member 452is positioned and oriented within the central portion 404 of the frame402 to substantially mirror an orientation and position of the firstportion 462 of the first member 452.

Further, once the first member 452 is positioned within the centralportion 404 of the frame 402, the tapered portions 472 are adjacent thelateral sides of the frame 402 with the intention to correspond or mimicthe shape of a PFO tunnel. Essentially, it is desired to have more ofthe tissue growth member 450 at intermediate portions of the firstportion 462 and second portion 464 of the first member to fill anypotential gap to, thereby, occlude the PFO tunnel. In this manner, thefirst member 452 may extend a greater dimension from the frame 402 at amiddle portion of the central portion 404 of the frame 402 than at oradjacent the lateral edges of the central portion 404 of the frame 402.

With respect to FIG. 13B, the second member 454 is depicted as being anelongated member extending between a first end 474 and a second end 476with a longitudinal axis 478 extending therethrough. The second member454 can include a first portion 480, a second portion 482 and a thirdportion 484, the second portion 482 being between the first and thirdportions 480 and 484. The second member 454 can include slots extendingfrom a bottom edge 490 to a central region (e.g., to about thelongitudinal axis 478 as depicted in FIG. 13B). The slots can include afirst slot 486 defined between the first portion 480 and the secondportion 482 and a second slot 488 defined between the second portion 482and the third portion 484. The second member 454 can also includetapered portions 492 defined adjacently between the first and secondportions 480 and 482 and the second and third portions 482 and 484. Thefirst end 474 and second end 476 can define beveled or rounded edges tolimit potential abrasion between the second member 454 and, for example,the tip portion of the catheter (not shown) when being constrictedtherein.

Referring now to FIGS. 12A and 13B, the second member 454 may be sizedand configured to be attached to a proximal portion of the frame 402and, more particularly, to proximal struts within the proximal cell 420and along a first proximal anchor segment 434 and a second proximalanchor segment 436. For example, the first end 474 can be attached to afirst anchor eyelet 438 and the second end 476 can be attached to asecond anchor eyelet 440. The first slot 486 is configured to correspondand receive a joint or interconnection between the first anchor segment437 and the proximal cell 420 and the second slot 488 is configured tocorrespond and receive a joint between the second anchor segment 436 andthe proximal cell 420. With this arrangement, the second member 454 canbe attached to a proximal portion of the frame 402 with additionalportions sewn to the frame 402, similar to the sewing shown in FIG. 11A.

Referring to FIGS. 12A, 12B, 13A and 13B, the first member 452 includesa longitudinal length dimension L1, a width dimension W1 and a depthdimension D1. Similarly, the second member 454 includes a longitudinallength dimension L2, a width dimension W2 and a depth dimension D2. Thedepth and width for each of the first and second member 452 and 454 maybe, but is not limited to, a substantially similar dimension. Asdepicted, the length L1 of the first member 452 may be greater than thelength L2 of the second member 454, however, note that the first member452 is employed as two barriers or layers comprising the first portion462 and second portion 464 each having a length of about L/2 (i.e., onehalf of L). Further, each respective length L1 and L2 is substantiallygreater than any other noted width or depth dimension of the tissuegrowth members. The depth D1 and D2 of the respective first member 452and the second member 454 is substantially greater than the width W1 andW2 of each of the first member 452 and the second member 454. Forexample, the respective width W1 and W2 of the first and second member452 and 454 may be approximately 1 mm to 3 mm and, preferably, betweenabout 1 mm and 1.5 mm. The respective depth D1 and D2 of the firstmember 452 and the second member 454 may be approximately 3 mm to 10 mmand, preferably, between about 4 mm and 6 mm. As such, the depthdimension D1 and D2 may be substantially larger than the width dimensionW1 and W2 and more particularly, may be in the order of ten timesgreater than each width dimension W1 and W2. Each of the respectivedepth dimensions D1 and D2 of the first and second member 452 and 454 isan important aspect of the invention, as will be set forth furtherbelow.

Further, as depicted in FIGS. 12A and 12B, according to an aspect of thepresent invention, the first member 452 and second member 454 positionedon the frame 402 extends substantially out-of-plane or substantiallyperpendicular relative to a plane 442 or flat configuration of the frame402. The depths D1 and D2 of the first and second members 452 and 454may each be three to twenty-five times greater than the depth-thicknessDT of the frame 402 and, preferably eight to seventeen times greaterthan the depth-thickness DT of the frame 402. With this arrangement,when the closure device 400 is positioned within the PFO tunnel (notshown in FIG. 12A or 12B) with the first and second lateral sides of theclosure device 400 expanding outward, the upper and lower walls of thePFO tunnel come into contact with the tissue growth member (since thetissue growth member 450 extends substantially perpendicular to theplane 442 of the frame 402) to, thereby, induce tissue growth thereto.In this manner, the first member 452 alone may provide the closurenecessary in the PFO tunnel with the first portion 462 of the firstmember 452 providing a first layer of tissue growth and the secondportion 464 of the first member 452 providing a second layer of tissuegrowth within the PFO tunnel. In addition, the second member 454 mayprovide an additional layer or third layer of tissue growth and closureto the PFO tunnel.

Further, due to the variability between different PFO tunnels, the firstmember 452 and the second member 454 together in their respectivestrategic locations attached to the frame 402 may provide greatersuccess in closing any given PFO tunnel. For example, fenestrations orother surface variations may be present in any given PFO tunnel. Thesecond member 454 is strategically positioned at a proximal portion ofthe frame 402 and, specifically, along portions of the proximal anchorsto address potential issues involving fenestrations or other surfacevariations in a PFO tunnel.

The respective depth dimension D1 and D2 of the first member 452 and thesecond member 454, extending substantially perpendicular to thesubstantially planar or flat configuration of the frame 402, providesstructure that advantageously maintains substantial contact with thetissue in the PFO tunnel to induce tissue growth through the first andsecond member 452 and 454 and to the tissue in the PFO tunnel. Further,due to the resilient, flexible and self expanding characteristics of thefirst and second member 452 and 454 extending out-of-plane, such firstand second members may slightly fold or compress so as to maintaincontact with the tissue in the PFO tunnel. The flexible nature of thefirst and second member 452 and 454, may maximize the surface area incontact with the tissue in the PFO tunnel despite the dynamic nature ofthe heart.

FIG. 14 illustrates another embodiment of a frame 502 of a closuredevice 500. In particular, in this embodiment, the frame 502 issubstantially similar to the frame of the previous embodiment, exceptthis frame 502 includes multiple clips 511 positioned at strategiclocations on the frame 502. The clips 511 are configured to grasp andattach, for example, the first member 452 and the second member 454(FIGS. 13A and 13B) to the frame 502. Each clip 511 includes a base 513and a cantilevered lever arm 515 that can be displaced to engage an armlatch 517 extending from the base 513. The base 513 may also includenubs 519 to provide assisted traction in holding a tissue growth member(not shown in FIG. 14). It should be noted that a tissue growth member,such as, for example the first member 452 and second member 454(depicted in FIGS. 13A and 13B), may be employed with the frame 502.

As depicted, each strut 514 of the first central cell 516 and the secondcentral cell 518 can include a clip 511. Further, the proximal cell 520can include a clip 511 on the inside wall portion of the two mostproximal struts 514 of the proximal cell 520. In addition, each proximalanchor 506 can include a clip 511 along the inside wall portion of aproximal anchor segment 534. In this manner, similar to that depicted inthe embodiment of FIG. 12A, the first member 452 and the second member454 can be attached to the frame 502 of this embodiment by utilizing theclips 511. If desired, the first member 452 and the second member 454may be additionally secured to the frame by sewing the ends and midportion to corresponding eyelets, as set forth in the previouslydescribed embodiment. This embodiment of the frame 502 with clips 511for attaching the first member 452 and second member 454 (FIG. 12A) maysubstantially stream-line manufacturing processes by eliminating, or atleast substantially reducing, the sewing of the tissue growth member tothe frame, thereby, saving time and increasing through-put in themanufacture of the closure device.

In one embodiment, the clips 511 may each be a seamless and unitarystructure of the frame 502. Such a seamless structure can be employed bylaser cutting the frame with each of the clips cut therewith from a flatsheet of metal, such as Nitinol metal. In this manner, the frame 502 ofthe closure device 500 can employ clips (that are seamless and unitaryto the frame structure) to attach a tissue growth member, such as foam,as previously described.

FIG. 15 illustrates another embodiment of a frame 602 of a closuredevice 600. This embodiment may be similar to the previous embodimentsin many respects, except this frame 602 may include an additional beamor distal reinforcing segment 629 for each distal anchor to provideadditional strength to the distal anchors as well as a differentconfiguration for some of the engaging members 622 on each of theproximal anchors. This embodiment also includes clips 611 for clippingthe tissue growth member (not shown) to the frame 602, which clips 611may be oriented differently from the previously described embodiment onthe proximal side of both the proximal anchors as well as the centralportion. As in the previous embodiments, the frame 602 may include acentral portion 604 with a first proximal anchor 606 and a secondproximal anchor 608 extending from the proximal side of the centralportion 604, and a first distal anchor 610 and a second distal anchor612 extending from the distal side of the central portion 604.

As previously set forth, this embodiment includes an additional beam oran additional distal reinforcing segment 629 for each of the firstdistal anchor 610 and the second distal anchor 612. Each distalreinforcing segment 629 may extend from a distal node or distal end 631of the central portion 604 of the frame 602 and connect adjacent theindicator 620 at the distal end 633 of the other more proximal segments628 of the first distal anchor 610 and the second distal anchor 612.Further, each distal reinforcing segment 629 can extend laterally fromthe distal end 631 of the central portion 604 to extend at leastpartially along-side the more proximal reinforcing segments 628 in asubstantially parallel manner.

Furthermore, each of the distal reinforcing segments 629 can include alongitudinal length dimension 635, a width dimension 637 and a depthdimension (not shown in FIG. 15). The length dimension 637, in theexpanded configuration can be substantially linear with each end portionhaving a curvilinear or arcuate portion, the curvilinear portion curvingand extending proximally to a connection point. The width dimension 637can include, for example, tapered portions 639 such that the widthdimension changes at one or more portions along the length thereof. Forexample, the distal reinforcing segment 629 can include a first portion641 and a second portion 643, the first portion 641 having a smallerwidth dimension than the second portion 643, a tapered portion providingthe transition between the first portion 641 and the second portion 643.Along the length of the distal reinforced segment 629 there can beseveral tapered portions or changes in width. The depth dimension of thedistal reinforced segment 629 may be similar to the depth dimension ofother portions of the frame (e.g., depth-thickness DT shown in FIG.12B).

Further, each distal reinforcing segment 629 of the first distal anchor610 and the second distal anchor 612 can be substantially coplanar witheach other such that they are each in a substantially flatconfiguration. In another embodiment, each distal reinforcing segment629 can be substantially coplanar with the central portion 604 and theother segments 628 of each distal anchor as well as substantiallycoplanar with the proximal anchors of the frame 602 such that the framesits in a substantially flat configuration.

With the distal reinforcing segments 629 of this embodiment, the closuredevice 600 can more readily maintain a stable position within a tissueopening, such as in a PFO in the heart, to resist pull-through anddisengagement from a deployed position. For example, pull-through canoccur when a physician deploys the closure device 600 in a PFO and thephysician manually pulls on the handle of the delivery device (not shownin FIG. 15) to determine if the closure device is firmly positionedwithin the PFO. Such reinforcing segments, cumulatively or incombination, provide resistance to pull-through so the physician canhave a more affirmative indication that the closure device is stabilizedwith the PFO through increased resistance. Such resistance topull-through may provide two to three times greater resistance than theprevious embodiments of the closure device that do not include theadditional distal reinforcing segment 629 of this embodiment.Furthermore, as previously set forth, certain portions of the distalreinforcing segments 629 may include a width dimension 637 greater thanother portions along the length dimension 635 or may include taperedportions 639. Such characteristics in the distal reinforcing segments629 provide for greater rigidity along certain portions of the lengththan on other portions, the portions with a greater width having thegreater rigidity of the distal reinforced segments. In this manner, theclosure device 600 can be deployed and refracted, in and out of thecatheter or delivery device, over numerous iterations without causingundue fatigue, stress or hardening within the struts and segments of theframe 602. Such tapered portions 639 are calculated to distribute andmanipulate the stress of the struts and segments of the frame 602 whenbeing deployed and/or when placed in a constricted orientation in, forexample, the tip portion of a catheter to maximize the strength of thestruts and segments while minimizing the mass and size of the frame 602.

As previously set forth, the currently described embodiment may includeengaging members 622, or otherwise referred to as miniature anchors, onthe distal side of both the first proximal anchor 606 and the secondproximal anchor 608. More particularly, according to one aspect of thepresent invention, the engaging members 622 exhibit a wave-crestconfiguration or profile. Such a wave-crest configuration includes abase portion 623, a peak portion 625 and a tip portion 627. The baseportion 623 may extend from a strut or segment of the frame 602 and, inthis embodiment, the distal surface of, for example, the first proximalanchor 606 or the second proximal anchor 608. The peak portion 625extends from the base portion 623 and can be sized and configured toinclude a curved surface (without a sharp point) or rather, anatraumatic surface. Such curved peak portion 625 is specifically sizedand configured to engage tissue without piercing the tissue that itengages. The tip portion 627 of the wave-crest profile extends downwardor back away from the peak portion 625 and provides an edge 619 (seeFIG. 16A) having a depth dimension (not shown) that extendssubstantially transverse to the plane of the closure device. The depthdimension of the edge 619 may be substantially the same as the depthdimension of the anchor segment from which the engaging member extends.In the presently considered embodiment, the depth dimension issubstantially larger than the width dimension of the proximal anchorsegments (as previously discussed in relation to aspect ratio), thereby,providing a substantial edge, along the depth dimension, sized andconfigured to aggressively engage tissue, but not configured to piercetissue.

With reference now to FIG. 16A, the engaging members 622, with thewave-crest configuration, are shown when the closure device is pulledinto a catheter 615. In the constricted, undeployed configuration withinthe catheter 615, the engaging members 622 are positioned directlyagainst the inside surface 617 of the catheter 615. With the wave-crestconfiguration, the peak portion 625 is positioned against the semi-hardsurface of the catheter 615. If the peak portion included an acuteoblique point, the closure device may not readily be able to be moved toa deployed orientation due to such point catching or causing resistanceagainst the surface of the catheter as the closure device is displacedrelative to the inside surface 617 of the catheter 615. However, thecurved, blunt surface of the peak portion 625 provides minimalresistance during such displacement to facilitate ready deployment ofthe closure device from the catheter 615. On the other hand, as depictedin FIG. 16B, when the engaging members 615 with the wave crestconfiguration are in contact and positioned against tissue 613, thetissue is conformable with such wave crest configuration, such that thecurved surface of the peak portion 625 provides an atraumatic surfacespecifically designed to engage, but not pierce the tissue 613 such asshown.

Further, the wave crest configuration will provide aggressive engagementor resistance in the direction of arrow 611 at the tip portion 627 andedge of the engaging members 622. With this arrangement, the engagingmembers 622 having the wave crest configuration provide advantages whenin contact with a hard surface, such as the inner surface 617 of acatheter 615 so as to limit resistance while providing aggressiveengagement with tissue 613 in a predetermined direction, arrow 611;atraumatic engagement at the peak portion 625 of the wave-crestconfiguration; and, further, non-piercing/atraumatic engagement at thetip portion 627 of the wave crest configuration when deployed adjacenttissue 613 or within a tissue structure, such as a PFO.

With reference now to FIG. 17, another embodiment of a frame 702 of aclosure device 700 is shown. The frame 702 of this embodiment is similarin many respects to a frame depicted in previous embodiments (e.g., FIG.3A). For example, the frame 702 may include a central portion 704 withfirst and second proximal anchors 706 and 708 extending from a proximalportion of the central portion 704. The frame also includes first andsecond distal anchors 710 and 712 extending from a distal portion of thecentral portion 704. The central portion 704 may include a plurality ofsegments or struts 714 that define a multi-cellular structure. In oneembodiment, the multiple struts 714 may define four cells: a firstcentral cell 716, a second central cell 718, a proximal cell 720 and adistal cell 722, the multiple struts 714 collectively defining thecentral portion 704 of the frame 702. Similar to previous embodiments,the frame 702 may be in the form of a generally flat plane orsubstantially planar (or may be described as including or exhibiting asubstantially flat configuration) such that the frame may remain in asubstantially flat configuration when constricted within the tip portionof the catheter (not shown) or at any other deployment stage. In oneembodiment, the first and second proximal anchors 706 and 708 may beco-planar with the central portion 404. In another embodiment, the firstand second distal anchors 710 and 712 may be co-planar with the centralportion 704.

In one embodiment, each cell may include four struts 714 defining aparticular cell. Adjacent cells may share one or more struts 714. Forexample, cells having four struts may include at least two struts 714that are common with two adjacent cells. Further, each cell may includeone or more nodes configured to interconnect adjacent struts 714.Furthermore, cells having four struts 714 may include four nodesassociated therewith, each node being associated with two adjacentstruts. Such nodes may additionally interconnect struts 714 of adjacentcells or, in other words, one cell may share one or more nodes ofadjacent cells. In one embodiment, the central portion 704 can includenine nodes: eight peripheral nodes and one central node. Theinterconnection of the nodes the struts 714 may define, in whole or inpart, the multi-cellular structure of the central portion 704, thecentral node interconnecting the struts 714 for each of the four cells.With this arrangement, the multi-cellular structure, including nodes andstruts, is configured to maximize outward expansion force while alsominimizing the material or mass required for such expansion force.

Further, as in the previous embodiments, the first and second proximalanchors 706 and 708 may include multiple proximal anchor segments todefine at least a portion of a closed periphery. Likewise, the first andsecond distal anchors 710 and 712 may include multiple distal anchorsegments to define at least a portion of a closed periphery. Forexample, the first proximal anchor 706 may include a first proximalanchor segment 724 extending from a right lateral node 736 of theproximal cell 720 and a second proximal anchor segment 726 extendingfrom a right-lateral node 738 of the first central cell 716, the firstand second proximal anchor segments 724 and 726 extending to andinterconnecting at a proximal anchor node 740. Such proximal anchor node740 may also be employed as an attachment portion for tethering theframe to the delivery system (not shown). Thus, a closed periphery or aclosed loop is defined by the anchor segments 724 and 726 in conjunctionwith nodes 736, 738 and 740.

In one embodiment, the first and second proximal anchors 706, 708 mayinclude an additional proximal anchor segment or a third proximal anchorsegment 728. Such third proximal anchor segment 728 may extend, similarto the first proximal anchor segment 724, between the right lateral node736 of the proximal cell 720 to the proximal anchor node 740. Further,the third proximal anchor segment 728 may extend substantially parallelto or along with the first proximal anchor segment 724. In oneembodiment, the third proximal anchor segment 728 may include a firstflexible portion 730 and a second flexible portion 732 with a rigidportion 734 extending therebetween. Each flexible portion may include ataper along a portion of a length of such flexible portion such that thetapering may extend or transition to the rigid portion 734. The firstproximal anchor segment 724, extending along-side the third proximalanchor segment 728, may include similar structural features as that ofthe third proximal anchor segment 728 or generally mirror the structuralfeatures thereof. In this manner, the third proximal anchor segment 728for each of the first and second proximal anchors 706 and 708 providesadditional resistance to the proximal anchors to prevent the closuredevice from moving or migrating to the left atrium of the heart (notshown in FIG. 17) when deployed in a PFO.

In addition, the frame 702 of the closure device 700 may include one ormore struts or dual struts extending along-side or substantiallyparallel with each other on the proximal side of the proximal cell 720.In comparison to the frame shown in FIG. 3A, the frame depicted in FIG.17 exhibits a first additional strut 742 extending between a proximalnode 746 of the proximal cell 720 to a right lateral node 736 of theproximal cell 720. Similarly, a second additional strut 744 can extendbetween the proximal node 746 of the proximal cell 720 to a left lateralnode 750 of the proximal cell 720. Further, similar to the other strutsof the central portion 704, the first and second additional struts 742and 744 may include a first flexible portion 752 and a second flexibleportion 754 with an intermediate rigid portion 756 therebetween. Theflexible portions 752 and 754 may taper or otherwise transition to therigid portion 756. With this arrangement, the first and secondadditional struts 742 and 744, in combination to the adjacent interiorproximal struts of the proximal cell 720, are configured to provideadditional resistance in comparison to a single strut configuration(e.g., see FIG. 3A) within the central portion 704 to minimize anypotential of the closure device moving or migrating to the left atrium.

Furthermore, in another embodiment, the frame 702 may include dualdistal struts of the distal cell 722 of the central portion 704 that mayextend along-side or substantially parallel with each other. Morespecifically, the distal cell 722 may include a first additional strut758 and a second additional strut 760, each extending from a distal node762 of the distal cell 722 to a right lateral node 764 of the distalcell 722 and a left lateral node 766 of the distal cell 722,respectively. Such first and second additional struts 758 and 760 of thedistal cell 722 can each include a first flexible portion 768 and asecond flexible portion 770 with a rigid portion 772 therebetween. Theflexible portions may be sized and configured to taper to or otherwisetransition to the rigid portion 772. In this manner, the dual struts ofthe distal cell 722 are sized and configured to provide additionalresistance, in comparison to a single strut configuration of the centralportion 704, in further preventing the closure device 700 from moving tothe right atrium, or provide additional pull through resistance whentethered to the delivery system.

In addition, the embodiment depicted in FIG. 17 may provide engagingmembers 780 having a wave-crest configuration such as described abovewith respect to FIGS. 15, 16A and 16B. The engaging members 780 may bepositioned along the second proximal anchor segment 726 (along a distalsurface of such segment) for both the first and second proximal anchors706, 708. As in the previous embodiment, the engaging members 780 aresized and configured to not pierce the tissue, but rather, aggressivelyengage the tissue if the closure device 700 moves toward the leftatrium, thereby, substantially preventing potential migration ormovement of the closure device 700 into the left atrium. In oneembodiment, as shown, engagement members having a wave-crestconfiguration may be located on the proximal anchors 706 and 708, butnot on the distal anchors 710 and 712. In another embodiment, engagementmembers having a wave-crest configuration may be located on any one, oron all of the anchors.

In another embodiment, in comparison to the embodiment depicted in FIG.3A, the first and second proximal anchors 706, 708 exhibit an increasedlength. With such increased length, the first proximal anchor segment724 and the second proximal anchor segment 726, at their initialcurvilinear extension from the central portion 704, include a firstradius 782 and a second radius 784, respectively, that is greater thanthe corresponding radii of the previous embodiment. Such larger radiiprovides a reduction in the strain exhibited in the first and secondproximal anchor segments 724 and 726 when the frame 702 is moved betweenan expanded configuration and a strained or stressed configuration, suchas when constricted within a catheter. It should be noted that the firstradius 782 and the second radius 784 of the first and second proximalanchor segments 724, 726, respectively, may be substantially similar.Additionally, the first and second radii 782 and 784 may be as large as,or larger than the radius of the strut or segment ends of adjacent cells(e.g., 716, 718 and 720).

In accordance with another aspect of the present invention, in oneembodiment, the structural lengths, tapers, rigid portions, etc. betweenvarious portions, i.e., struts, anchor segments, etc., of the frame 702may be similar with other like or similar portions in order toeffectively and substantially symmetrically facilitate movement betweena strained position within a catheter and an expanded position deployedfrom a catheter. For example, in one embodiment, the structuralcomponents for one half of the frame or right side of the frame may beequivalent or substantially a mirror image of the structural componentsfor the other half or left side of the frame. In another embodiment, thestruts 714 that define each of the four cells of the central portion704, may be substantially similar in length, with substantiallyequivalent flexible portions, tapered portions and rigid portions. Inanother embodiment, the distal most struts 714 in the distal cell 722include a substantially similar length. In another embodiment, thedistal struts 714 of the first and second central cell 716 and 718(which include the proximal struts of the distal cell 722) include asubstantially similar length. Similarly, in another embodiment, theproximal struts 714 of the first and second central cell 716 and 718include a substantially similar length. In still another embodiment, theproximal most struts 714 of the proximal cell 720 include asubstantially similar length.

Furthermore, the various anchor segments of the first and secondproximal anchors 706 and 708 and the first and second distal anchors 710and 712 include common relationships in order to effectively andsubstantially symmetrically strain or stress the frame 702 when isconstrained within an associated catheter or other delivery device. Forexample, the first proximal anchor segment 724 is substantially the samelength as the second proximal anchor segment 726. The first proximalanchor segment 724 extending between the right lateral node 736 of theproximal cell 720 and the proximal anchor node 740. The second proximalanchor segment 726 extending between the right lateral node 738 of thefirst central cell 716 and the proximal anchor node 740. It should benoted that the undulations in the second proximal anchor segment 726(that also include the engaging members 780) facilitate the range ofmotion of the first and second proximal anchors 706 and 708 in beingstrained and moved in a proximal direction when being constricted withina catheter (similar to that depicted in FIG. 3B). When constrictedwithin a catheter, the undulations typically may not completelystraighten and, therefore, the second proximal anchor segment 726 may beslightly longer than the first proximal anchor segment 724. In thismanner, the symmetrical characteristics between the various structuralcomponents of the frame minimize fatigue in the frame and maximize asmooth transition between an un-deployed and deployed state of the frame702 with respect to the catheter.

Further, in another embodiment, first and second distal anchors 710 and712 of the frame 702 may exhibit common lengths within their respectivedistal anchor segments. For example, first and second distal anchorsegments 786 and 788 or reinforcing segments, in combination with thelength of the strut 714 between the right lateral node 738 of the firstcentral cell 716 and the right lateral node 764 of the distal cell 722,may be substantially similar in length to a third distal anchor segment790 extending between the right lateral node 738 of the first centralcell 716 and a distal anchor node 792. As shown, the third distal anchorsegment 790 exhibits undulations to increase the length of the thirddistal anchor segment 790 and allow the distal anchors with thenecessary range of motion to move to the constricted position in acatheter or other delivery device. When in the constricted position, theundulations of the third distal anchor segment 790 may not completelystraighten and, thus, the third distal anchor segment 790 may beslightly longer than the length of the first and second distal anchorsegments 786 and 788 plus the length of the strut 714, as previously setforth.

Now referring to FIGS. 18 and 19, another embodiment of a closure device800, depicting an unfinished process for attaching a tissue growthmember 802 to a frame 804 of the closure device 800. In particular, inthis embodiment, the tissue growth member 802, may be thermally weldedto, or about, the central portion 806 of the frame 804. As depicted, thetissue growth member 802, such as foam, may be thermally welded to oneor more struts 808 of the central portion 806. The process of thermallywelding may include a welding fixture 810 sized and configured to clampdown, for example, on both sides of a strut 808 within the centralportion 806 and with two layers of a tissue growth member 802therebetween. The welding fixture 810 heats and fuses the tissue growthmember 802 together at an approximate predetermined temperature to,thereby, attach the tissue growth member 802 to particular struts of thecentral portion 806 of the frame 804. Once the tissue growth member 802is thermally welded to the frame, as depicted in FIG. 18, the tissuegrowth member 802 may then be cut or otherwise trimmed to a desiredconfiguration, generally similar to that depicted in FIG. 12A or anyother suitable configuration. It should be noted that the configurationmay vary slightly from that depicted in FIG. 12A due to the tissuegrowth member being thermally welded to both sides of selected struts808 or the central frame segments. Further, various slits or openingsmay be cut or formed within the thermally welded foam (for example,within the cells of the central portion 806) that will facilitate thetissue growth member to readily conform between a constrainedorientation within a catheter, and an expanded, un-constrained (orminimally constrained, as-deployed) orientation.

With respect to FIG. 20, another embodiment of the previously describedclosure device 700 is provided. This embodiment is similar to thatdepicted and described with respect to FIG. 17, except this embodimentdoes not include the first and second additional struts 758 and 760(FIG. 17) distal the distal cell 722 of the frame 702. This embodimentdoes, however, include the first and second additional struts 742 and744 or central frame segments proximal the proximal cell 720. Further,this embodiment also may exhibit the additional proximal anchor segmentsor the third proximal anchor segment 728 for each of the first proximalanchor 706 and the second proximal anchor 708. Further, the frame mayalso include the engaging members 780, as previously described, on thefirst and second proximal anchors. In addition, this embodiment maydefine various eyelets 733 in the first and second proximal anchors 706,708. The eyelets 733 may also be defined in the central frame segmentsor central frame struts 714 as well as the first and second additionalstruts 742, 744. Such eyelets 733 may be employed, for example, forsewing a tissue growth member (not shown) thereto. The frame 702 of theclosure device 700, depicted in this embodiment, may include a tissuegrowth member for inducing tissue in-growth, as previously described,that may be attached, for example, via stitching, sewing, clipping, orby adhesive with a similar configuration as that depicted and describedwith respect to FIGS. 12A and 12B, or it may be thermally attached aspreviously set forth in conjunction with FIGS. 19 and 20.

As previously set forth, the frame may be a generally flat frame orsubstantially planar or includes a substantially flat configuration whenin an expanded configuration and resists movement out of suchsubstantially planar or flat configuration. Further, the first andsecond proximal anchors may be co-planar with the central portion.Likewise, the first and second distal anchors may be co-planar with thecentral portion. Further, the frame may remain in a substantially flatconfiguration when constricted within the tip portion of the catheter orat any other deployment stage.

The present invention may be embodied in other specific forms withoutdeparting from its spirit or essential characteristics. The describedembodiments are to be considered in all respects only as illustrativeand not restrictive. Various features of one embodiment may be describedin features of other embodiments. The scope of the invention is,therefore, indicated by the appended claims rather than by the foregoingdescription. All changes which come within the meaning and range ofequivalency of the claims are to be embraced within their scope. Thus,it should be understood that the invention is not intended to be limitedto the particular forms disclosed. Rather, the invention includes allmodifications, equivalents, and alternatives falling within the spiritand scope of the invention as defined by the following appended claims.

1. An expandable medical device deployable at least partially within atissue structure and adjacent a left atrium of a heart, the expandablemedical device comprising: a multi-cellular central frame portionconfigured to self expand from a first, non-tubular orientation to asecond, non-tubular orientation, the first orientation beingsubstantially similar to a collapsed orientation within a catheter, thesecond orientation being substantially similar to an orientation whereinthe central frame portion is deployed and operable substantially withinthe tissue structure and adjacent the left atrium, said central frameportion comprising a plurality of interconnecting central frame supportsegments defining at least two apertures, at least one of said centralframe support segments having a length and a width, the width varyingalong at least a portion of the length; and at least one anchor linkedto said multi-cellular central frame portion.
 2. A medical device asrecited in claim 1, wherein said central frame portion is configured toassume a substantially flat configuration when in the second, nontubular orientation.
 3. A medical device as recited in claim 1, whereinsaid at least one anchor comprises a first proximal anchor and a secondproximal anchor each including a plurality of anchor frame segments,wherein at least two of the anchor frame segments extend substantiallyparallel to each other along at least a portion of their respectivelengths for each of the first proximal anchor and the second proximalanchor.
 4. A medical device as recited in claim 1, wherein said centralframe support segments defining said multi-cellular central frameportion including at least two central frame support segments extendingsubstantially alongside each other.
 5. A medical device as recited inclaim 1, wherein said at least one anchor comprises engaging membershaving a wave-crest configuration.
 6. A medical device as recited inclaim 1, wherein said at least one anchor comprises engaging membershaving a blunt peak portion and an edge configured to aggressivelyengage tissue, said edge defined lower than said peak portion.
 7. Amedical device as recited in claim 1, further comprising a tissue growthmember configured to be attached to said central frame portion andconfigured to induce tissue growth.
 8. A medical device as recited inclaim 7, wherein the tissue growth member comprises an elongated memberpositioned along at least one of the central frame support segments ofthe central frame portion and configured to be positioned within thetissue structure.
 9. A medical device as recited in claim 7, wherein thetissue growth member extends along opposing sides of at least one of thecentral frame support segments of the central frame portion and isconfigured to be positioned within the tissue structure.
 10. A medicaldevice as recited in claim 7, wherein the tissue growth member comprisesa polymeric material.
 11. A medical device as recited in claim 7,wherein at least one of the central frame portion and the at least oneanchor comprise one or more clips, the one or more clips beingconfigured to attach the tissue growth member to at least one of thecentral frame portion and the at least one anchor.
 12. A medical deviceof claim 1, wherein said at least one anchor and said central frameportion are a unitary and seamless frame structure.
 13. An expandablemedical device deployable at least partially within a hole defined in atissue structure between a first atrium and a second atrium of a heart,the hole defining an axis oriented axially through the hole, theexpandable medical device comprising: a frame configured to assume asubstantially flat configuration oriented substantially parallel to, orextending substantially along, the axis of the hole when in an intended,as-deployed state within the tissue structure, said frame comprising acentral portion, at least one proximal anchor and at least one distalanchor, said frame adapted to move between a first orientation and asecond orientation, said central portion comprising a plurality of framesegments defining a multi-cellular structure, said at least one proximalanchor and said at least one distal anchor each configured to extendsubstantially coplanar with said central portion, and said at least oneproximal anchor configured to extend in the first atrium and said atleast one distal anchor configured to extend in the second atrium. 14.The medical device of claim 13, wherein said frame comprises a unitaryand seamless frame structure.
 15. A medical device as recited in claim13, wherein said frame is configured to assume said substantially flatconfiguration lying in a first plane, said frame being configured toresist movement out of said first plane of the substantially flatconfiguration.
 16. A medical device as recited in claim 13, wherein saidat least one proximal anchor comprises engaging members having awave-crest configuration.
 17. A medical device as recited in claim 13,wherein said at least one proximal anchor comprises engaging membersextending from a segment of the at least one proximal anchor to a bluntpeak portion and having an edge configured to aggressively engagetissue, said edge being positioned between the segment of the at leastone proximal anchor and said peak portion.
 18. A medical device asrecited in claim 13, further comprising a tissue growth memberconfigured to be attached to said frame and configured to induce tissuegrowth.
 19. A medical device as recited in claim 18, wherein the tissuegrowth member comprises an elongated member positioned along the centralportion of the frame and configured to be positioned in the hole andoriented substantially transverse to the axis of the hole.
 20. A medicaldevice as recited in claim 18, wherein the tissue growth membercomprises: a first elongate tissue growth portion positioned along thecentral portion of the frame and configured to be positioned in the holeand oriented substantially transverse to the axis of the hole; and asecond elongate tissue growth portion positioned proximal to the firstelongate tissue growth portion, the second elongate tissue growthportion configured to be oriented substantially transverse to the axisof the hole.
 21. A medical device as recited in claim 18, wherein thetissue growth member comprises a polymeric material.
 22. A medicaldevice deployable at least partially within a hole defined in a tissuestructure, the hole defining an axis oriented axially through the hole,the medical device comprising: a framework configured to assume asubstantially flat configuration oriented substantially parallel to, orextending substantially along, the axis of the hole when in a state forintended deployment within the tissue structure, said frameworkcomprising a central portion and at least one anchor extending from saidcentral portion, said central portion including central frame segmentshaving a length and a width, wherein the width of at least one of saidcentral frame segments varies along at least a portion of the length ofsaid at least one of said central frame segments in a taperedconfiguration.
 23. A medical device as recited in claim 22, wherein saidcentral frame segments of said central portion define a multi-cellularstructure.
 24. A medical device as recited in claim 22, wherein said atleast one anchor comprises a first proximal anchor and a second proximalanchor each including a plurality of anchor frame segments, wherein atleast two of the anchor frame segments extend substantially parallel toeach other along at least a portion of their respective lengths for eachof the first proximal anchor and the second proximal anchor.
 25. Amedical device as recited in claim 22, wherein said at least one anchorcomprises engaging members having a wave-crest configuration.
 26. Amedical device as recited in claim 22, wherein said at least one anchorcomprises engaging members extending from a segment of the at least oneanchor to a blunt peak portion and having an edge configured toaggressively engage tissue, said edge being positioned between thesegment of the at least one anchor and said peak portion.
 27. A medicaldevice as recited in claim 22, further comprising a tissue growth memberconfigured to be attached to said framework and configured to inducetissue growth.
 28. A medical device as recited in claim 27, wherein thetissue growth member comprises an elongated member positioned along thecentral portion of the framework and configured to be positioned in thehole and oriented substantially transverse to the axis of the hole. 29.A medical device as recited in claim 27, wherein the tissue growthmember comprises: a first elongate tissue growth portion positionedalong the central portion of the framework and configured to bepositioned in the hole and oriented substantially transverse to the axisof the hole; and a second elongate tissue growth portion positionedproximal to the first elongate tissue growth portion, the secondelongate tissue growth portion configured to be oriented substantiallytransverse to the axis of the hole.
 30. A medical device as recited inclaim 27, wherein the tissue growth member comprises a polymericmaterial.
 31. A medical device deployable at least partially within ahole defined in a tissue structure, the hole defining an axis orientedaxially through the hole, the medical device comprising: a frameworkconfigured to assume a substantially flat configuration orientedsubstantially parallel to, or extending substantially along, the axis ofthe hole when in a state for intended deployment within the tissuestructure, said framework comprising a central portion and at least oneanchor extending from said central portion, said central portionincluding central frame segments, at least one of said central framesegments including a longitudinal length dimension and having an aspectratio of a depth dimension to a lateral width dimension of at least 2 to1, wherein said depth dimension is defined to extend substantiallyperpendicular relative to said substantially flat configuration of saidframework.
 32. A medical device as recited in claim 31, wherein saidcentral frame segments of said central portion defines a multi-cellularstructure.
 33. A medical device as recited in claim 31, wherein said atleast one anchor comprises a first proximal anchor and a second proximalanchor each including a plurality of anchor frame segments, wherein atleast two of the anchor frame segments extend substantially parallel toeach other along at least a portion of their respective lengths for eachof the first proximal anchor and the second proximal anchor.
 34. Amedical device as recited in claim 31, wherein said at least one anchorcomprises engaging members having a wave-crest configuration.
 35. Amedical device as recited in claim 31, wherein said at least one anchorcomprises engaging members extending from a segment of the at least oneanchor to a blunt peak portion and having an edge configured toaggressively engage tissue, said edge being positioned between thesegment of the at least one anchor and said peak portion.
 36. A medicaldevice as recited in claim 31, further comprising a tissue growth memberconfigured to be attached to said framework and configured to inducetissue growth.
 37. A medical device as recited in claim 36, wherein thetissue growth member comprises an elongated member positioned along thecentral portion of the framework and configured to be positioned in thehole and oriented substantially transverse to the axis of the hole. 38.A medical device as recited in claim 36, wherein the tissue growthmember comprises: a first elongate tissue growth portion positionedalong the central portion of the framework and configured to bepositioned in the hole and oriented substantially transverse to the axisof the hole; and a second elongate tissue growth portion positionedproximal to the first elongate tissue growth portion, the secondelongate tissue growth portion configured to be oriented substantiallytransverse to the axis of the hole.
 39. A medical device as recited inclaim 36, wherein the tissue growth member comprises a polymericmaterial.
 40. An expandable medical device deployable at least partiallywithin a hole defined in a tissue structure between a first atrium and asecond atrium of a heart, the hole defining an axis oriented axiallythrough the hole, the medical device comprising: a framework configuredto assume a substantially flat configuration oriented substantiallyparallel to, or extending substantially along, the axis of the hole whenin a state for intended deployment within the tissue structure, saidframework comprising a central portion, a first proximal anchor, asecond proximal anchor and at least one distal anchor extending fromsaid central portion, wherein said first and second proximal anchors areconfigured to extend in the first atrium and said at least one distalanchor configured to extend in the second atrium; wherein said firstproximal anchor and said second proximal anchor each include a pluralityof anchor frame segments, wherein at least two of the plurality ofanchor frame segments extend substantially parallel to each other alongat least a portion of their respective lengths for each of the firstproximal anchor and the second proximal anchor.
 41. A medical device asrecited in claim 40, wherein said at least one proximal anchor and saidat least one distal anchor are each configured to extend substantiallycoplanar with said central portion.
 42. A medical device as recited inclaim 40, wherein said central portion comprises multipleinterconnecting central frame segments defining a multi-cellularstructure.
 43. A medical device as recited in claim 40, wherein saidcentral portion comprises central frame segments having a length and awidth, wherein the width of at least one of said central frame segmentsvaries along at least a portion of the length of said at least one ofsaid central frame segments in a tapered configuration.
 44. A medicaldevice as recited in claim 40, wherein said central portion comprisescentral frame segments, at least one of said central frame segmentsincluding a longitudinal length dimension and having an aspect ratio ofa depth dimension to a lateral width dimension of at least 2 to 1,wherein said depth dimension is defined to extend substantiallyperpendicular relative to said substantially flat configuration of saidframe.
 45. A medical device as recited in claim 40, wherein said firstproximal anchor and said second proximal anchor comprise engagingmembers, at least one of the engaging members having a wave-crestconfiguration.
 46. A medical device as recited in claim 40, wherein saidfirst proximal anchor and said second proximal anchor comprise engagingmembers, at least one of said engaging members extending from a segmentof its respective anchor to a blunt peak portion and having an edgeconfigured to aggressively engage tissue, said edge being positionedbetween the segment of the respective anchor and said peak portion. 47.A medical device as recited in claim 40, wherein said central portioncomprises central frame segments, at least two central frame supportsegments extending substantially alongside each other.
 48. A medicaldevice as recited in claim 40, further comprising a tissue growth memberattached to said framework.
 49. A medical device as recited in claim 48,wherein the tissue growth member comprises an elongated memberpositioned along the central portion of the framework and configured tobe positioned in the hole and oriented substantially transverse to theaxis of the hole.
 50. A medical device as recited in claim 48, whereinthe tissue growth member comprises: a first elongate tissue growthportion positioned along the central portion of the framework andconfigured to be positioned in the hole and oriented substantiallytransverse to the axis of the hole; and a second elongate tissue growthportion positioned proximal to the first elongate tissue growth portion,the second elongate tissue growth portion configured to be orientedsubstantially transverse to the axis of the hole.
 51. A medical deviceas recited in claim 48, wherein the tissue growth member comprises apolyurethane foam.
 52. A medical device as recited in claim 48, whereinthe tissue growth member comprises a porous member configured to inducetissue in-growth.
 53. A medical device as recited in claim 48, whereinthe tissue growth member comprises a polymeric material.
 54. A medicaldevice as recited in claim 48, wherein the tissue growth member isconfigured to substantially extend out-of-plane relative to thesubstantially flat configuration.
 55. A medical device as recited inclaim 48, wherein the tissue growth member comprises a longitudinallength, a width and a depth, the depth configured to substantiallyextend out-of-plane relative to the substantially flat configuration,the depth being a greater dimension than the width.
 56. A medical deviceas recited in claim 48, wherein the framework comprises a frame depththickness defining a thickness of the substantially flat configuration,the depth of the tissue growth member having a dimension that is aboutthree to about twenty-five times greater than the frame depth thickness.57. A medical device as recited in claim 48, wherein the frameworkcomprises a frame depth thickness defining a thickness of thesubstantially flat configuration, the depth of the tissue growth memberhaving a dimension that is about eight to about seventeen times greaterthan the frame depth thickness.
 58. A medical device as recited in claim48, wherein at least one of the central frame portion and the at leastone proximal anchor comprise one or more clips, the one or more clipsbeing configured to attach the tissue growth member to at least one ofthe central frame portion and the at least one anchor.
 59. An expandablemedical device deployable at least partially within a hole defined in atissue structure between a first atrium and a second atrium of a heart,the hole defining an axis oriented axially through the hole, the medicaldevice comprising: a frame configured to assume a substantially flatconfiguration oriented substantially parallel to, or extendingsubstantially along, the axis of the hole when in a state for intendeddeployment within the tissue structure, said frame comprising a centralportion and at least one proximal anchor and at least one distal anchorextending from said central portion, and said at least one proximalanchor configured to extend in the first atrium and said at least onedistal anchor configured to extend in the second atrium; and a tissuegrowth member attached to the frame, the tissue growth membercomprising: a first elongate tissue growth portion positioned along thecentral portion of the frame and configured to be positioned in the holeand oriented substantially transverse to the axis of the hole; and asecond elongate tissue growth portion positioned proximal to the firstelongate tissue growth portion, the second elongate tissue growthportion configured to be oriented substantially transverse to the axisof the hole.
 60. The medical device of claim 59, wherein the firstelongate tissue growth portion and the second elongate tissue growthportion are configured to provide multiple layers of tissue growth toocclude the hole in the tissue structure.
 61. The medical device ofclaim 59, wherein the tissue growth member comprises a third elongatetissue growth portion positioned proximal to the first elongate tissuegrowth portion, the third elongate tissue growth portion configured tobe oriented substantially transverse to the axis of the hole.
 62. Themedical device of claim 61, wherein the third elongate tissue growthportion is positioned along the at least one proximal anchor and alongthe central portion of the frame.
 63. The medical device of claim 59,wherein the second elongate tissue growth portion is oriented on thecentral portion of the frame to substantially mirror an orientation ofthe first elongate tissue growth portion.
 64. The medical device ofclaim 59, wherein the tissue growth member is configured tosubstantially extend out-of-plane relative to the substantially flatconfiguration.
 65. The medical device of claim 64, wherein the firstelongate tissue growth portion comprises a longitudinal length, a widthand a depth, the depth configured to substantially extend out-of-planerelative to the substantially flat configuration, the depth being agreater dimension than the width.
 66. The medical device of claim 64,wherein the frame comprises a frame depth thickness defining a thicknessof the substantially flat configuration, the depth of the first elongatetissue growth portion having a dimension that is about three to abouttwenty-five times greater than the frame depth thickness.
 67. Themedical device of claim 64, wherein the frame comprises a frame depththickness defining a thickness of the substantially flat configuration,the depth of the first elongate tissue growth portion having a dimensionthat is about eight to about seventeen times greater than the framedepth thickness.
 68. The medical device of claim 59, wherein the tissuegrowth member comprises a foam material.
 69. The medical device of claim59, wherein the tissue growth member comprises a polyurethane foammaterial.
 70. The medical device of claim 59, wherein the tissue growthmember comprises a polymeric material.
 71. The medical device of claim59, wherein the tissue growth member comprises a biocompatible materialconfigured to induce tissue growth.
 72. The medical device of claim 59,wherein at least one of the central frame portion and the at least oneanchor comprise one or more clips, the one or more clips beingconfigured to attach the tissue growth member to at least one of thecentral frame portion and the at least one anchor.